PHARMACEUTICAL INTERVIEW QUESTION AND ANSWERS
Short Question-Answer
1. Quarantine: The status of
starting or packaging materials, intermediates or bulk or finished products
isolated physically or by other effective means while a decision in awaiting on
their release or refusal or rejection or reprocessing. On the other hand, the
status of materials, intermediates or products set apart while awaiting a
decision on their suitability for reprocessing or for sale or distribution.
2. Segregation: Segregation means
separating or setting apart. It is the process to separate materials or
products according to their nature for avoiding mix-up and easy traceability.
The process, which takes place in, the formation of germ cells in which is each
gamete receives only one of each pair of genes. Separation of one product from
other product to avoid contamination and mix-up.
3. Ambient Temperature: Ambient
temperature means the temperature surround us. In a pharmaceutical industry,
this temperature range between 25ºC – 30ºC. Ambient conditions to be 30ºC where
as other provisions accepted 25ºC – 30ºC. Ambient in the immediate location
usually a reference to temperature or humidity.
4. Cold/Cool Temperature: A
temperature range between 2º C – 8º C is called cool temperature and cold
temperature range between 8º C – 15º C.
5. Cold Chain Product Temperature: The
temperature is which the raw materials of a product its manufacture, storage,
distribution up to prescription is done within 2ºC – 8ºC is known as cold chain
product temperature
6. Control Condition Temperature: The
temperature between 20ºC – 25ºC is known as control condition temperature or
control room temperature.
7. Batch: A defined quantity of
starting material, packaging material or product processed in one process or
series of processes so that it could be expected to be homogeneous. Batch means
a specific quantity of a drug or other materials that is intended to have
uniform character and quality within specified limits and is produced according
to a single manufacturing order during the same sycle of manufacture.
8. Batch no.: A distinctive combination
of numbers and/or letters which specifically identifies a batch or lot on the
labels, the batch records, the certificates of analysis etc. A designation in
number or letters or combination there of that identifies the batch and permit
the tracing of the complete history of a batch, including all stages of its
production, control, distribution and dispensing.
9.
Component: Component means any ingredient intended for use in the
manufacture of a drug product including those that may not appear in such drug
product. Any product contains more than one material and each material is
called component.
10.
Drug – Product: „Drug Product‟ means
a finished dosage forms (e.g. Tablet, Capsule, Solution etc.) that contains an
active drug ingredient generally but not necessarily in association with
inactive ingredients. The term also includes a finished dosages form that does
not contain an active ingredients but is indeed to be use as a placebo. Any
substance or mixture of substances that is manufactured, offered for sale or
presented for use in (1) the treatment, mitigation, cure, prevention or
diagnosis of disease, abnormal physical state or the symptoms there of in man
or animal or (2) the restoration, correction or modification of organic
functions in man or animal.
11. Active Ingredients: Active
ingredient means any component that is intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment
or prevention of disease or to effect the structure of any function of the body
of man or other animals the term includes those components that may undergo
chemical change in the manufacture of the drug product in a modified form
intended to furnish the specified activity or effect.
12. Excipient: Excipients are the
additives used to convert pharmacologically active compounds in a
pharmaceutical dosage forms suitable for administration of patients. Excipient
is non-drug component of a pharmaceutical formulation. Excipients include
diluents, binders and adhesive, fillers, disintegrants, lubrications, glidents,
flow promoters, colors, flavours and sweetness. The general notice on excipient
state that any substances added in official preparation shall not interfere
with the assays and tests of the pharmacopoeia. It shall be innocuous shall
have no a verse influence on the therapeutic efficacy of the active ingredient.
Excipients are those substances which are not biologically active and are
mainly used along with the active ingredient of a drug product to make the
product more stable e.g magnesium stearate, Starch, Purified talc etc.
13. Inactive Ingredient: „Inactive
ingredient‟
means any component other than an active
ingredient. Inactive ingredient states that any substances added in official
preparation shall not interfere with the assay and test of the Pharmacopeia.
Inactive ingredient usually makes up the major portion of the final dosage
form.
14. Bulk Product: Any products,
which has completed all processing stages up to, but not including final
packing. Any processed product, which still has to undergo the packing
operation in order to become a finished product. The product following
purification, but before final formulation. It is obtained form a bulk harvest,
and is kept in a single container and used in the preparation of the final
dosage form.
15.
Finished Product: A medicinal product, which has undergo all stages of
manufacturing operations including packaging in its final container and
labeling.
16. In Process Materials: In process
material means any material fabricated compounded, blended or derived by
chemical reaction that is product for and used in the preparation of the drug
product. All substances, whether active or inactive or whether they remain
unchanged or become altered, that are employed in the manufacture of drugs.
17.
Strength: Strength means the concentration of the drug substances (for
e.g. weight/ weight, weight / volume or unit dose and or the potency of a drug
product). A quantitative measure of active ingredient as well as other
ingredients requiring quantitation such as alcohol and preservatives.
18.
Potency: Potency means the therapeutic activity of the drug product as
indicated by appropriate laboratory tests or by adequately developed and
controlled clinical data. The potency of drug is indicated on the label.
Potency may be expressed in terms of units of a reference standard, as in 100
IU of vitamin E, or in weight, weight equivalent or percent of active
ingredient. The potency of drug is some times referred to as the strength of
the drug.
19.
Efficacy: Property of drug to active the desired response. A manufacture
has to prove both safety and efficacy for the FDA to approve a new drug
application. It is a term used to know the response of any drug produced
whether optimum or not. A product must be biological effective as it is claimed
to be from its dosage form the drug itself is required to be biologically
available to the recipients.
20. Theoretical Yield: „Theoretical Yield‟ means the quantity that would be obtained at any appropriate
phase of manufacture, processing or packing of a particular drug product, based
upon the quantity of components to be used, in absence of any loss or error in
actual production.
21. Actual Yield: „Actual Yield‟ means the quantity that is actually produced at any
appropriate phase of manufacture, processing or packing of a particular drug
product. On the other hand the quantity that is actually produced at any phase
of production of a particular drug product from a given amount of ingredient.
22. Representative Sample: Representative Sample means a sample that
consists of a number of units that are drawn based on rational criteria such as
random sampling and intended to assure that the sample accurately portrays the
material being sampled. A sample accurately portraying the lot, the batch or
the total amount of materials being sampled.
23. Validation: The
documented act of proving that any process, procedure, equipment, material,
activity, system or mechanism used in manufacture or control can achieve the
describe and intended result. It is an intended part of Quality Assurance. The action
of proving a high degree of assurance that a specific process will consistently
produce a product meeting its predetermined specification and quality
attributes validation includes installation qualification, operating
qualification and performance qualification activities.
24. Revalidation:
Revalidation means the repetition of the validation process or a specific
portion of it. When there is change in validation process or any main factors
affecting product quality consideration should be given whether revalidation is
necessary.
25. Media Fill: It is the method of evaluating effectiveness
of an aseptic process by filling container with culture medium instead of the
product, incubating the containers and checking for microbial growth. At least
3000 articles should be used in media fill and the accepted limit 0.1%. It is
the method validation intended for sterile area for a particular number of
people.
26. Biological Indicator: Biological indicator generally is
highly resistant bacterial spores present in greater number then the normal
contamination of the product and with equal or greater resistance than normal
microbial flora in the products being sterilized. Biological indicators are
standardized preparation of resistant organisms, usually in sporulating form,
of one species used for the validation of sterilization, while Bacillus
stearothermophilus is preferred for steam sterilization. Biological indicator
are those organisms used to indicate a particular condition. The term most
commonly applied for coliform bacteria e.g. Ecoli or streptocoecus facealis
indicat the degree of water pollution due to faecal contamination. Biological
indicators should be considered only as an additional method for monitoring the
sterilization. If they are us used, strict precautions should be taken avoid
transferring microbial contamination from them.
27. Non Biological Indicator:
non biological indicator are those substances or chemical agents which
indicates a particular condition either by change in colors or by the change of
their present state. e.g. Sterilization step is a kind of non biological
indicator which shows brown color after completion of a successful moist heat
sterilization cycle. 28. OTC Drug: Over the Counter drug. OTC drugs are
those drugs which can be used without the prescription of a registered
physician.
29. HVAC: Heating, Ventilation, Air conditioning system is
used for temperature and humidity control with in a manufacturing environment.
It include air handling units air distribution network, air cooling and heating
system, air filtration, equipment control system, monitoring and alarm device.
HVAC system are an integral part of clean room design. The primary purpose of
an HVAC system is to provide a specific set of environmental conditions required
for the manufacturing process.
30. Back Sipnonage: Back
sipnonage is the process to prevent the back flow of water or other unusual
liquids. It is a one way system to pass the water outside. Back sipnonage means
back flash of water.
31. Material / Product Traceability: It is the
process to trace all materials and products in all stages of manufacture and
distribution. All aspects of the procedure including calibration, specification
of the reagents and other operational parameters are well defined. The
measurement should be on sound chemical and physical principles described in
the literature and thoroughly tested. It should always be possible to trace
back all the relevant information about a pre tested sample as and when
necessary. Traceability is the most prominent concept used by analytical chemist
to characterize quality of measurements. It is the chain of comparison from
measurements back to the standard of same kind by reference to which one can
estimate the uncertainly of the results.
32. HEPA: High Efficiency
Particular Air Filter (HEPA) is a filtering system. HEPA filter capable of
retaining 99.97 percent of particles as small as 0.3 μm. It is a disposable,
extended media dry type filter in a rigid frame.
33. Accuracy: Accuracy
defines the agreement between the true value and the value found in the
testing. The closeness of the result obtained during measurement or analysis to
the true value. Bias is a systematic deviation from the true value. It normally
refers to the difference between the mean of the set of results of analysis of
the unknown are compared with the results obtained from the analysis of
standards or reference materials. Accuracy expresses closeness of agreement
between the value, which is accepted either as a conventional true value or an
accepted reference value and the value found. Accuracy can be determined by
comparing the results with those obtained using an alternative method which has
already been validated. Accuracy may be determined by applying the procedure to
samples of the material to be examined that have been prepared with
quantitative accuracy. For analytical methods there are two possible ways of
determining the accuracy; the so- called absolute method and the comparative
method.
34. Precessions: Precession
defines the closeness of agreement between a series of measurements obtained
from multiple sampling of the same homogeneous sample under the prescribed
conditions. It is a measure of degree of repeatability or reproducibility under
normal conditions. Precision may be defined as the concordance of a series of measurements
of the same quality. Accuracy expresses the correctness of a measurement, and
precession the reproducibility of a measurement. Precession always accompanies
accuracy, but a high degree of precession does not imply accuracy. The degree
of variation between individual tests results when the method is used
separately to separate sample drawn from the same homogeneous batch of
material. This will includes variation between analysis between days between
tests on the same prepare extract of a given sample, between extracts and
between laboratories
conducting the same test. Precession is usually expressed as a standard
deviation or coefficient of variation.
35. Repeatability: Repeatability
express the precession under the same operating conditions over a short
interval in time. It is relating to testing performed over a short time
interval. This is the precession of the method when repeated by the same
analyst, same test method and under same set of laboratory condition with in a
short interval of time, the only difference being the sample. The repeatability
of any test procedure is required to be assessed by caring out complete
separate determination or separate samples of the same homogeneous batch of
material under normal condition. This is the criteria of concern for compendia
assay procedures.
36. Reproducibility: Reproducibility expresses the
precession between laboratories. It relates to the collaborative studies
between laboratories. This evaluation is the measure of the robustness of the
method since many variables are involved-different facilities, different
equipment, different analysts different reagents. This is a key element in
analytical verification and conformation that a new laboratory obtained
equivalent result to the originator laboratory. When the subject method is
carried out by different conditions on different days- variability of
analytical results as function to equipment etc. using the samples from same
homogeneous batch problems connected with reproducibility of the test results
are naturally compounded when tests are performed in different countries. When
discussing confidence in test results a major concern is assuring a sufficient
degree results with the high degree of precession and be described in
reproducibility.
37. Robustness: Robustness of an analytical procedure is
a measure of its capacity to remain unaffected by small, but deliberate,
variations in method parameters and provides an indication of its reliability
during normal use. It is the ability of the procedure to provide analytical
results of acceptable accuracy and precision under a verity of conditions. It
is a measure of the extent to which the result obtained from separate
putatively identical samples of the same homogeneous batch of material are
influenced by changes in operational or environment condition but are constant
with the specification and down for procedure.
38. Linearity: The linearity of an
analytical procedure is its ability to procedure results that are directly
proportional to the concentration of analyte in the samples. Linearity applies
only to methods involving quantification and involves the demonstration of a
linear response over the range being evaluated. Exam. An assay method may be
evaluated only over the range of 85 – 115% of the specification since any
results outside of these values would be out of specification. Linearity is
ability of the method of elicit test results that are directly proportional to
the concentration of analyte.
39.
TDS: TDS means Total dissolve solid. The amount of solid present in
dissolved state in DM or Tape water. Tape water, DM water have pharmacopieal
requirement for TDS.
40. Regeneration System: Regeneration means the
regaining of previous condition. It means to gain the original strength of
anything by define protocol. In DM water plant by exchanging the cationic
anionic reaction, the resin regains its in initial states. The exchange depends
on activity series. During absorption of mineral, the resin looses its
absorbing capacity and a layer forms on resin by the accumulation of materials.
Thus after a period of time the resin requires regeneration by red alarm on the
display board. The machine shows red alarm on the basis of conductivity e.g.
The range is (0.1 – 1.0) μs. It is exceeds the machines shows continuously red
alarm to stop the supply of DM water and to go for regeneration.
41. Manufacturing:
The complete set of activities to produce a drug comprising of production and
quality control from acquisition of all materials through processing and
subsequent packaging to the release for distribution of the finished product.
The complete cycle of operations involved in the production from receipt of
materials, through processing and packaging, to release as a finished product.
All operation of purchase of materials and products, Production, quality
Control, release, storage, distribution of medicinal products and related
control.
42. Reprocessing: The reworking of all or part of batch of
product of an unacceptable quality from a defined step of production in order
its quality may be rendered acceptable by one or more additional operations.
Reprocessing or reworking may be required for many reasons the most common
causes are potency adjustments, failure to meet physical parameters, non
uniform blending etc. Reprocessed batch must be thoroughly tested to make sure
that its meets the required specifications.
43. Campaign basis:
Different products prepare in the same area, sharing same facilities with
proper cleaning method or validation. Production on a campaign basis may be
acceptable for other spore forming organisms provided that the facilities are
dedicated to this group of products and no more than one product is processed
at any one time. The campaign manufacturing (e.g. Sharing the same facilities
between manufacture of two or more different products) with fulfillment of
validated clean down approach, is regarded as the minimum effort to avoid
cross-contamination. Such procedure obviously will demand a highly motivated
work force. During “campaign manufacturing” or any routine manufacturing, the
process control measures will help solve major risks of cross-contamination.
44. Consistency: An acceptable number e.g. five successive batches of
final dosage form should be characterized as fully as possible to determine
consistency of composition. Any differences between one batch and another should
be as the basis for produce specification.
45. Master formula: A document
stating the starting materials, with their quantities, to be used in the
manufacture of a medicinal product, together with a description of the
manufacturing operation including details of specific in process controls, but
normally
excluding
packaging information. A document or set of documents specifying the starting
materials with their quantities & the packaging material together with a
description of the procedure and precautions required to produce a specified
quantity of finished products as well as the processing instructions including
the in-process control.
46. BMR: Batch Manufacturing Record. A document
stating the materials used and the operation carried out during the processing
of a given batch including details of in process control. It should be based on
the master formula and be complied as the manufacturing operation process.
After completion of stability study, PDD prepare batch manufacturing record on
the basis of product formula and product specification for manufacturing
process validation. BMR contents product name, strength, Batch no, Batch size,
Quantity, Quantity of raw material, code no, QC reference no, Calculation on
potency, manufacturing procedure, temperature, humidity, time, Yield of
different stage etc.
47. BPR: Batch Packaging Record. A document stating
the bulk product and packaging material used and the process carried out during
the packaging of a given batch with details in process control. It should be
based on the master formula & packaging instruction and be complied during
the packaging operation. BPR contents Product name, strength, Batch no, Batch
size, Pack size, MRP, Mfg. date, Exp. Date, Outer box / Shipping carton size
etc.
48. Stability Study: It is the study which is used to determine
appropriate storage condition and self life stability study is observed to
determine the self life of a product i.e. how much time the product remain
stable in the market and confirms with product specification meet the
pharmaceutical limit. Stability study observed by two methods. (i) Accelerated storage
test. (ii) Storage test method
49. Accelerated S. Study: A test
performed to determine the rate of degradation of drugs or other substance to
product the self life of the product. The study is performed by accelerating
the degradation process by increasing temperature, humidity or light and
determine the corresponding rate of degradation of a drug substance or drug
product by using exaggerated storage condition. The purpose is to determine
kinetic parameters, to predict the tentative expiration dating period. The term
“accelerated” is often used synonymously with “stress testing”. To predict the
stability of a new product the accelerated testing approach is a doped.
Degradation of the product by adopting various extreme storage conditions such
as higher humidity and higher temperature as mentioned earlier. For a simple
product where the decomposition is constant over a temperature range and the
order of reaction kinetics is also known, it is relatively easier to calculate
the t½ (half
life) and t90 (10%
decomposition). For the first order reaction kinetics the equation for a. 0.693
0.105
t½
= -------------- and t90 = ------------- k1 k1
where k1
is the rate constant for the 1st order reaction. So when the rate
constant and the order of reaction of a drug substance is
known
the self life (t90)
can be easily calculated. The equation will obviously differ for a different
order of reaction.
50. Real Time S. Study: Real time stability study is
done by storing the product at ambient condition through out its self life
after launching.
51. Mfg. Date: A date fixed for the individual batch
including the completion date of manufacture. A specified date for the
individual batch including the date of bulk product manufacture.
52. Exp. Date: A date fixed for each
individual batch before which the batch iii meets the required standard
specifications for quality. A specified date for the individual batch based on
the stability of the product, beyond which it may fail to meet the required
quality input for its intended use “Expiry Date” in relation to a medicinal
product means the date after which the product should not be used. If the
expiration date includes only a month and a year, it is expected that the
product will meet specifications through the last day of the month.
53. Pre
Formulation: It is one step a head of final formulation. Pre formulation is
the common physico-chemical tests; such as meeting point, thermal analysis,
polymorphic studies, Stability etc. Usually carried out for newly synthesized
drug.
54. Recipe: Recipe is a list of active ingredients and excipients
of a drug, which is to be submitted to drug administration for approved. To
produced quality product the step; to taken in account at standard chain is
mainted is called be Recipe on the other hand it can be described an predefined
protocol to manufacture drugs.
55. Annexure: Annexure is the approved
recipe or license obtained of a drug form drug administration. It is a document
which stats the total Recipe of any product approved by appropriate Drug
Control Authority. The formulation so approved by the regulatory Drug
Authority.
56. DAR No.: “DAR NO” means Drug Administration Registration
Number. DAR No. is a specific combination of numbers or approval given by the
drug administration to manufacture a product.
57. Self – Inspection: Self-inspection
means to assess myself and opportunity for improvement with respect to
guidelines like GMP ISO9001 FDA or National regulatory discipline.
Self-inspection is to evaluate the manufactures with GMP in all aspects of
production and quality control. Self-inspection is required for the
implementation of corrective action and to examine effectiveness of improved
system. Self-inspection team consisting of at least 3 members who are expert in
their own fields and familiar with GMP.
58.
Pressure vessel: It is a closed vessel to which pressure is added to
transfer the solution either through filter or directly in to the fined closed
vessel form which filling and sealing is done. A vessel which is used to filter
sterile product by using wet gas pressure.
59. Membrane filter : Membrane filter
which is used in sterile filtration of parenteral products. It is a cellulose
ester membrane use for filtration process to remove microorganisms from liquid.
The pore size of the membrane filter may range from 0.2μ to 0.45μ. A 0.22μ
filter is considered a sterilizing filter. Filter medium produced from
cellulose derivatives of polymeric materials. Membrane filters, which have
discrete uniform passages that penetrate from one side of the media to the
other can be regarded as fine, uniform capillaries. Membrane filter holders
accept membranes from 13 to 293 mm in diameter.
60. Bubble pt. Test: The
bubble point test is a popular single point physical integrity test for dise
filter membrane. Nondestructive integrity test of a filter membrane based on
the amount of pressure required to force air through a wet porous membrane has
a specific bubble point. A test at a pressure of 20 pounds/squire inch is
sufficient to detect leaks. Membrane filters, which have discrete uniform
passages that penetrate from one side of the media to the other, can be
regarded as fine uniform capillaries. The bubble point test is based on the
fact that when these capillaries are full of liquid, the liquid is held by
surface tension. The minimum pressure required to force the liquid out at the
capillary pressure is higher in the case of a small pore than in that of a
large pore. The same is true for pores in a membrane. The bubble point pressure
is governed by the following equation 4γcosθ i. P = K ------------------ D P =
Bubble point pressure K = Shape correction factor D = Pore diameter γ = Surface
tension of the liquid θ = Liquid-to-membrane contact angle
61. Pre Filter:
Filter that traps gross particulate matter. Pre filters are located upstream
from other filters (e.g. HEPA filter) and have a lower collection efficiency
than the other filters. Pre filter is the filter which is used before final and
main filtration.
62. Intermediate Filter: Intermediate Filter present
between the final filter and pre filter. 63. HEPA Filter: The HEPA
(Highest Efficient Particulate Air) filter is disposable, extended-media dry
type filter in a rigid frame. HEPA filter capable of retaining 99.97 percent of
particles as small as 0.3 micrometers. The filter medium is very fine glass
fibers mounted in a rigid frame. The HEPA filter sometimes called the absolute
filter.
64. Air Vent Filter: It is a filter used to vent air from a
closed vessel during with drawls sterile solution from or entry of sterile
solution in to the vessel to protect product from being contamination. In a 0.2
micro pore size filter which is used to administration sets for intravenous
solutions when air elimination though manipulative procedures in inefficient.
65.
Sparkler Filter: Sparkler filter is the electric filter for liquid
product. It is the filter generally used to liquid product filtration purpose
in order to get sparkling filtrate. Sparkler filter is a special type of filter
in which liquid is passed through cloth/coarse paper positioned between two net
plates one after by pressure.
66. Press Filter: It is the most versatile
of filters since the number of type of filter sheets can be varied to suit a
particular requirement. It can be used for coarse to fine filtrations, and any
special conduct arrangement for multistage filtration with in single press. The
filtrate equipment in which filter pad is used by pressure. It is a simplest
kind of pressure filter, which is used for filtration of liquids by using high
pressure. Filter presses are used for a high degree of classification of fluid
and for the harvesting of cake. It can be used for coarse to fine filtration.
The press filter is the most versatile of filters and it is the most economical
filts per unit of filtering surface which can be used for coarse to fine
filtrations. The normal range of flow of this filter is three gallons per
minutes per square foot of filter surface at pressures of up to 25 psi.
67. Filter
Aid: It is special type of filter medium which is used to forms a fine
surface deposit that screen out all solids preventing them from contacting and
plugging the supporting filter medium.
68. Microbial Alert Level: Microbial
alert level is that the level of microorganism that shows a potential drift
from normal operating condition. On the other hand Microbial levels which, when
exceeded should result in an investigation to ensure that the process is still
with in control. Exceeding alert level is not necessary ground for corrective
action but it should at least prompt a documented follows up investigation. It‟s a control limit for environmental monitoring level.
69. Microbial
Action Level: It is the level of microorganism that when exceed requires
immediate follow up and necessary corrective action. Microbial levels in the
controlled environment which, when exceeded should trigger an investigation and
corrective action based on the investigation. Action limit is to allow
corrective measures without affecting the batches or production.
70. Time
Limitations on Production: It is the actual time needed or total time
needed to complete a batch of product with respect to standard machine
specification, man power and other equipments.
71. Pyrogen: In Greek
word “Pyrogen” means “Production of fever” any substance that produces a fever.
Pyrogens are products of the metabolism or portions of the protein coat of
bacteria. The most potent pyrogens are often found as contaminations in
paranteral drugs, thus drugs are tested for pyrogenicity with the rabbit test
or limulus lysate test fever is a response to fever including substance called
pyrogens including bacterial endotoxins, that enter the blood as a result of
the death of microorganisms or are released by phagocytic blood cells.
72.
LAL: LAL stands for “Limulus Amoebocyte Lysate” test. This test
determines the presence or the concentration of endotoxin in products. It is
the bacterial indotoxin test reagent. LAL test used to detect minute quantities
of bacterial endotoxins and other pyrogens using an extract from the circulting
amebocytes from the horseshoe crab (limulus polyphemus). Aspect of validation
based on endotoxin despruction is the extration of dried endotoxin from the
commodity for testing by the Limulus Amebocy Lysate( LAL test).
73. Endotoxin: Bacterial Endotoxin or
pyrogen is metabolic products of living micro-organism or the dead
micro-organism causing a specific pyretic response upon injection. It is the
part of Gram –ve bacterial cell wall, also known as lipopoly succharide (LPS).
It is liberated when the cell wall of the bacteria ruptures or broken down.
74.
Rabbit Test: Rabbit test is also called pyrogen test. Test of pyrogen
based on temperature rise in rabbits following the intravenous infection of a
test solution. The pyrogen test is a method to test the existence of pyrogens
by using rabbits. The test is carried out on a group of three rabbits. If two
or three rabbits show an individual rise of 0.6° or more above the respective
control temperature. The test shall be considered as positive when the pyrogen
test is positive the sample is considered to be rejected.
75. Leak Test: Test performed in
ampoules, tablet and capsule blisters either by dye immersion under pressure or
by high capacitance method to detect leaks. It is performed in ampoules to
detect on incomplete seal, capacity pores or tiny creaks. The test uses dyes or
pressure to disclose leaked. This is performed to determine the lot average
weight loss or leakage as measured over time loss is due to leakage of CPCS
through the valve seals USP requirements are usually adopted. One product
recall has occurred due to excessive leakage rates.
76. Air Locks: An
enclosed space with two or more doors, which is interposed between two or more
rooms e.g. of differing classes of cleanliness, for the purpose of controlling
the air flow between these rooms when need to be entered. Each area having
different qualities of environment or different air pressures, in the latter
case it can be termed a “Pass through hatch”. An air lock can also by the
“anteroom” too clean room in which sterile goods are handled.
77. Air Shower:
A high speed flow of air, helps to sweep of particles and microorganism from
garments and body.
78. Air Curtain: Air curtain created between two
temperature difference room. A current of air directed around a patient so that
air that would normally circulate around and contaminate the patient is blocked
by the curtain of air which is used in isolating patients from dust-borne
bacteria or allergens.
79.
Positive Pressure: Positive pressure are the pressure created in the
aseptic production area to avoid contaminated air pass in. It gradually
decreases in the successive rooms. It is used to prevent contaminated air from
flowing in to the clean room. Positive pressure areas should be used to process
sterile products but negative pressure in specific areas at point of exposure
of pathogens is acceptable for containment reasons.
80. Differential Pressure: Differential Pressure means the pressure difference between two adjacent rooms. Different of air pressure between two rooms with in the sterile area this may very from 10 – 25 pressure.
81. Depyrogenation Temperature: Depyrogen means free from Pyrogen an a parenteral drug. The temperature at which the Ptrogen are killed Depyrogenation temperature are dry heat at 200ºC for one hour and 250ºC for half an hour.
82. Moist Heat Temperature & Pressure for Sterilization: Sterilization by moist heat is suitable only for water-wettable materials and aqueous solution both temperature and pressure should be used to monitor the process. The moist heat temperature for sterilization is 121ºC and the pressure for sterilization is 15Ibs pressure/square inch.
80. Differential Pressure: Differential Pressure means the pressure difference between two adjacent rooms. Different of air pressure between two rooms with in the sterile area this may very from 10 – 25 pressure.
81. Depyrogenation Temperature: Depyrogen means free from Pyrogen an a parenteral drug. The temperature at which the Ptrogen are killed Depyrogenation temperature are dry heat at 200ºC for one hour and 250ºC for half an hour.
82. Moist Heat Temperature & Pressure for Sterilization: Sterilization by moist heat is suitable only for water-wettable materials and aqueous solution both temperature and pressure should be used to monitor the process. The moist heat temperature for sterilization is 121ºC and the pressure for sterilization is 15Ibs pressure/square inch.
83. Air Velocity: It is the air speed generated by laminar air flow equipment. The air velocity is LAF work bench is 70-110 feet/ min. Air velocity is detected by anomometer. Measurement of the velocity of air flow in a controlled environment to demonstrate that the air systems balanced and capable of delivering sufficient air volumes to maintain a minimum cross sectional velocity. Recommended air speeds are 0.30 meters per second for vertical and 0.45 meters per second for horizontal flow.
84. Positive Controls: Positive controls is a culture medium which is used for sterility test is checked for its efficacy to support growth of different organism by adding 10-100 cfu of m gm. This is known as positive control.
85. Negative Controls: Negative controls are the culture media without addition of product sample or microbial challenge. The –ve control as used to velocity the sterility of the medium before during and after the incubation period of the sterility tests.
86. Challenge Test: Microbial challenge test of a filter is the ability of a filter to retain particles or microorganisms involving filtration. The test means of determining the bacterial retention properties of the system. For Example hot doptet is a challenge test for HEPA filter. On the other hand in microbial challenge test a standardized culture containing a large number of small microorganisms such as pseudomonas diaminula, is fillered and the presence of bacteria in the filtrates, indicate the failure of the filter. This is sensitive test because of the large number of organism used and because the organisms self-replicate & allow even low numbers of bacteria that might pass through a filter.
87.
Preservative Deactivation Test: In pharmaceutical preservative is
commonly used to prevent microbial growth. This test is carried out for
particle to cheek that any bacteriostatic and fungiotatic activity of the
article do not adversely affect the reliability of the test. The preservative
can be deactivated either by dilution or using suitable chemical agent like
easeir peptone, polisorbate 80 etc.
88. UCL (Upper Control Limit): UCL denotes Upper Control Limit. It is the maximum limit permitted either in weight or volume or potency of a product above which the weight or volume or potency of the product will not accepted. It is the manufactures in-house limit. Example: The upper control limit of a APA tablet is 663 mg where as its control points 650 mg.
89. MCL (Middle control Limit): MCL denotes Middle control Limit. It is the desired weight or volume or potency of a product. For example 650 mg is the MCL of APA tablet. 90. Emulsion: Emulsion are usually liquid preparation which are prepared by addition emulsifying agent and purified water to liquid drugs. It is two phase system in which are liquid is dispersed in the form of small droplets through ought another liquid. It is a stable mixture of two immiscible liquids combined with surfactants to change there compatibility with stabilizers that increases viscosity.
91. External Liquid: External liquid are the liquid preparation which are used externally on the skin and not to take orally. External liquid is the liquid preparation other than oral liquid. It is used external body like kevilon, Savlon, Detol etc.
88. UCL (Upper Control Limit): UCL denotes Upper Control Limit. It is the maximum limit permitted either in weight or volume or potency of a product above which the weight or volume or potency of the product will not accepted. It is the manufactures in-house limit. Example: The upper control limit of a APA tablet is 663 mg where as its control points 650 mg.
89. MCL (Middle control Limit): MCL denotes Middle control Limit. It is the desired weight or volume or potency of a product. For example 650 mg is the MCL of APA tablet. 90. Emulsion: Emulsion are usually liquid preparation which are prepared by addition emulsifying agent and purified water to liquid drugs. It is two phase system in which are liquid is dispersed in the form of small droplets through ought another liquid. It is a stable mixture of two immiscible liquids combined with surfactants to change there compatibility with stabilizers that increases viscosity.
91. External Liquid: External liquid are the liquid preparation which are used externally on the skin and not to take orally. External liquid is the liquid preparation other than oral liquid. It is used external body like kevilon, Savlon, Detol etc.
92. Topical Preparation: It is the soft semisolid preparation for external application to the skin or mucous membrane for systemic fungal or bacterial infection. It is a preparation which are most commonly used are ointments and lotion. A number of topical medicaments are applied to the skin, eye, nose, throat, ear and vagina etc. These are the dry or semisolid preparation used in external body like Neocin powder and another antibiotic powder etc.
93. LCL (Lower Control Limit): It is the lowest limit accepted either weight or volume or potency of a product. For example if standard weight of APA tablet is 650 mg and in house limit is 2% than lower control limit is 637 mg.
94. ATCC (American Type Culcuture Collection): ATCC stands for American Type Culcuture Collection. It is a institution which gives a specific number to different organisms based on the variation of the strain.
95. LVP (Large Volume Parenteral): “Large
Volume Parenteral” means a terminally sterilized aqueous drug product packaged
in a single dosage container with a capacity 100 ml or more and intended to be
administered or used in man. It includes intravenous infusions, irrigating
solutions, peritoneal dialysates and blood collecting units with anticoagulant.
Single dosage form that is intended for parenteral use and is packaged
in containers holding 100 ml or more. It is commonly used to refer to injection
only but the definition includes irrigation solutions, peritoneal dialysates
and blood collecting units with anticoagulant. Containers containing 100 ml or
more of the injectable solution is termed as large volume. They are usually
used by the intravenous route.
96. SVP: Small Volume Parenteral include an extremely wide range of preparations and containers-closures. Small Volume Parenterals are the drug packed in a container of not more than 100 ml in volume. They are a diverse and heterogeneous group of drugs. This category of parenterals include Ampoules of 1 ml, 2 ml, 3 ml and vials of 2 ml, 5 ml, 10 ml etc. They may be suitable for intramuscular, intravenous, intra dermal, subcutaneous, intra spinal, intra-cisternal or intrathecal use.
97. Particle: Particles are the substances which are either biological or non biological origin, with observable length width and thickness i.e, dust particle, talc, bacteria and fungi etc. A very small piece or part of matter, a tiny fragment or trace is particle. One of several subatomic components of the nucleus of radioactive elements such as alpha and beta particles. Particles are biological or non biological origin.
98. Source of Particulate Matter: The source of particulate matter are Man, Machine, Materials, Garments, walls, ceiling, floor etc.
99. Oral Liquid: Oral liquid are liquid preparations intended for oral administration that contain ore or more substances with or without flavoring, sweetening or coloring agents dissolved in water. Liquid for oral use are usually solutions emulsions or suspensions containing one or more active ingredients in a suitable vehicle. Some liquids for oral administration may consist of liquid active ingredients.
96. SVP: Small Volume Parenteral include an extremely wide range of preparations and containers-closures. Small Volume Parenterals are the drug packed in a container of not more than 100 ml in volume. They are a diverse and heterogeneous group of drugs. This category of parenterals include Ampoules of 1 ml, 2 ml, 3 ml and vials of 2 ml, 5 ml, 10 ml etc. They may be suitable for intramuscular, intravenous, intra dermal, subcutaneous, intra spinal, intra-cisternal or intrathecal use.
97. Particle: Particles are the substances which are either biological or non biological origin, with observable length width and thickness i.e, dust particle, talc, bacteria and fungi etc. A very small piece or part of matter, a tiny fragment or trace is particle. One of several subatomic components of the nucleus of radioactive elements such as alpha and beta particles. Particles are biological or non biological origin.
98. Source of Particulate Matter: The source of particulate matter are Man, Machine, Materials, Garments, walls, ceiling, floor etc.
99. Oral Liquid: Oral liquid are liquid preparations intended for oral administration that contain ore or more substances with or without flavoring, sweetening or coloring agents dissolved in water. Liquid for oral use are usually solutions emulsions or suspensions containing one or more active ingredients in a suitable vehicle. Some liquids for oral administration may consist of liquid active ingredients.
100. Suspension: A suspension is a preparation of finely divided undissolved drugs, dispensed in a liquid phase. It is a two phase dosage system in which a finely divided solid in mixture with, but not dissolved in a fluid. Suspension are usually liquid preparation which are prepared by adding suspending agents or other suitable excipients are purified water or oil to splid drugs.
101. Dry Powder for Suspension: Dry powder for suspension are preparations of finely powdered drug intended for suspension in liquid vehicles. They are generally reconstituted with recommended volume of purified water. A dry mixer of an Antibiotic e.g. Ampicillin, whenmixed with one or more suitable buffers, preservatives, stabilizers, sweetening agent and suspending agents suitable for reconstitution are called dry powder for suspension. It is also called dry syrup. Powders are preparation in powdered form. Powders are usually prepared by uniformly mixing drugs with or without diluents, binders, disintegrators or other suitable excipients by a suitable method to produce a pulverized or finally granulated form. If necessary coloring agents, aromatic agents, flavoring agents etc may be added.
102.
Suppository: Suppositories are solid preparation intended to insertion
in to the rectum, urethra or vaginal cavity. Suppositories are usually prepared
by molding uniform mixers of drugs and bases in to a suitable shape.
Suppositories melt or soften at body temperature or dissolve slowly in the
secretions. Suppositories are usually prepared by by mixing drugs with fat-type
bases water-miscible bases or other suitable materials. A semisolid substance
for introduction in to the rectum, vagina or urethra where it dissolves. It
often suffers as a vehicle for medicines to be absorbed. Commonly shaped like
cylinder or cone and made of soap, glycerinated gelatin or cocoa butter.
103. Ointment: Ointment are usually homogeneous, semisolid preparations for external application, as such consistency that they may be applied to the skin by in unction. It is topical dosage form generally consisting of a hydrocarbon semisolid base, containing dissolved or suspended drugs. Ointments are usually prepared from fats, fatty oils, lanolin, petrolatum, paraffin, waxes, resins, glycols, higher alcohols, glycerin, water by mixing homogeneously other drugs with the foregoing materials as bases. Ointments are free from rancid odor.
104. Cream: Semisolid emulsion system with opaque appearance. It may be a water in-oil or oil in – water type. It is high fat portion of milk. It is pale yellow and is used in making whipped cream. Creams are formulated to provide preparations that are necessary and essentially miscible with the skin secretion. They are intended to be applied to the skin or certain mucous membranes for protective, therapeutic or prophylactic purpose especially where an occlusive effect is not necessary.
103. Ointment: Ointment are usually homogeneous, semisolid preparations for external application, as such consistency that they may be applied to the skin by in unction. It is topical dosage form generally consisting of a hydrocarbon semisolid base, containing dissolved or suspended drugs. Ointments are usually prepared from fats, fatty oils, lanolin, petrolatum, paraffin, waxes, resins, glycols, higher alcohols, glycerin, water by mixing homogeneously other drugs with the foregoing materials as bases. Ointments are free from rancid odor.
104. Cream: Semisolid emulsion system with opaque appearance. It may be a water in-oil or oil in – water type. It is high fat portion of milk. It is pale yellow and is used in making whipped cream. Creams are formulated to provide preparations that are necessary and essentially miscible with the skin secretion. They are intended to be applied to the skin or certain mucous membranes for protective, therapeutic or prophylactic purpose especially where an occlusive effect is not necessary.
105. Purpose of Coating: Coating is like a cover of core tablets. To protect the tablet from light, moisture, temperature and finally for the elegance of the product. Coating of a tablet using powdered granule. It is prepared by feeding previously compressed tablets in to a special machine and compressing another granulation layer around the preformed tablets. Oral tablet coated with a sugar or film coating. The purpose of coating are- i) To mask bitter and unpleasant taste and odor and color of the drug ii) To overcome stomach or Gastric irritation iii) To overcome decomposition of the drug iv) To maintain prolong action v) To make tablets shape smooth vi) Improved esthetic qualities of the product vii) Enabling the product to more easily swallowed by the patient and improving product stability. viii) To provide physical and chemical protection for the drug. ix) To incorporate another drug or formula adjuvant in the coating to avoid chemical incompatibilities or the provide sequential drug release. x) Modifying drug release characteristics and to improve the pharmaceutical elegance by use of special colors and contrasting printing.
106.
Ref. Standard: Ref. Standard are the primary standard, which are
established, held distributed by the appropriate international and national
organization. Ref. standard is the material with which the test material is to
be compared before deciding about its quality. Ref. Standards prepared by the
producer should be tested, released and then stored in the same way as official
standards. Ref. Standards may be available in the form of official standards.
107. Working Standard: Working standard are preparation in the laboratory, whose potency have been determined by an adequate number of comparative tests in relation to the relevant primary standard. Working standard may be established by the application of appropriate tests and cheek at regular intervals to ensure standardization.
108. LOD: Loss on drying. It is the expression of moisture content on a wet-weight basis. The loss of drying test is a method to measure the loss in weight of the sample when dried under the conditions specified in each monograph. This method is applied to determine the amount of water, all or a part of water of crystallization or volatile matter in the sample, which is removed during the drying. The description for example not more than 1% (1 gm, 105º, 4 hours) in a monograph. On a wet-weight basis the water content of a material is calculated as a percentage of the wet solid. The water lost by evaporation is read directly from the percent LOD scale. It is assured that there are no other volatile materials present. LOD is calculated as follows:
107. Working Standard: Working standard are preparation in the laboratory, whose potency have been determined by an adequate number of comparative tests in relation to the relevant primary standard. Working standard may be established by the application of appropriate tests and cheek at regular intervals to ensure standardization.
108. LOD: Loss on drying. It is the expression of moisture content on a wet-weight basis. The loss of drying test is a method to measure the loss in weight of the sample when dried under the conditions specified in each monograph. This method is applied to determine the amount of water, all or a part of water of crystallization or volatile matter in the sample, which is removed during the drying. The description for example not more than 1% (1 gm, 105º, 4 hours) in a monograph. On a wet-weight basis the water content of a material is calculated as a percentage of the wet solid. The water lost by evaporation is read directly from the percent LOD scale. It is assured that there are no other volatile materials present. LOD is calculated as follows:
109. MC: MC stands Moisture Content. It is the measurement of the moisture in a wet solid. Calculated on a dry-weight basis. This value is referred to as moisture content or MC. The MC value change from slightly above 0% and approach infinity. MC is a for realistic value than LOD in the determination of dryer load capacity.
110. SD (Standard Deviation): The standard deviation (σ) is the square root of the mean of the sum of the square of the difference between the value of the mean of those values and of the particular value in connection with the normal distribution. Statistical calculation for expressing the variability or spread of data is SD. The larger the spread of the numbers in a data set, the larger the standard deviation. It is the square root of the variance. In analytical chemistry one of the most common Statistical terms employed is the Standard Deviation of a population of observation. This is also called the root mean square deviation as it is the square root of the mean of the sum of the squares of the difference between the values and the mean of those values and is of particular value in connection with the normal distribution.
111. RSD (Relative Standard Deviation): The square of the standard deviation is called the variance. A further measure of precision, known as the Relative Standard Deviation is given by: RSD = s/x Relative Standard Deviation is Standard Deviation divided by Arithmetic mean. RSD = s/x Where S= Standard Deviation, x = Mean value.
112.
GMP: Good Manufacturing Practice is that part of Quality Assurance which
insure that products are consistently produced and controlled the quality,
standards appropriate to their intended use and required by the marketing
authorization or product specification.
113. S.O.P.: A written authorized procedure that gives instruction for performing operation not necessary specific to a given product or materials, but of amore general nature (e.g. Equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection, etc) Certain standard operation procedure may be used to supplement the product specific master and batch production documentation.
114. Method Validation: Method validation is the process used to confirm the analytical procedure employed for the specific test is suitable its intended uses.
115. Master Formula: Documents used in pharmaceutical manufacturing generally containing the name, description, strength of a product, batch size, a complete test of ingredients, quantities of ingredients, specification of each ingredients used in product, theoretical yield, manufacturing and control instruction, containers labeling and packing materials.
116. Stability study: It is the study to determine the self-life of a product how much time the product remain stable in the market and confirm with product specification meet the pharmacopoeia limit.
113. S.O.P.: A written authorized procedure that gives instruction for performing operation not necessary specific to a given product or materials, but of amore general nature (e.g. Equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection, etc) Certain standard operation procedure may be used to supplement the product specific master and batch production documentation.
114. Method Validation: Method validation is the process used to confirm the analytical procedure employed for the specific test is suitable its intended uses.
115. Master Formula: Documents used in pharmaceutical manufacturing generally containing the name, description, strength of a product, batch size, a complete test of ingredients, quantities of ingredients, specification of each ingredients used in product, theoretical yield, manufacturing and control instruction, containers labeling and packing materials.
116. Stability study: It is the study to determine the self-life of a product how much time the product remain stable in the market and confirm with product specification meet the pharmacopoeia limit.
117. Specification: A document giving a description of a starting material, packing material, intermediate bulk or finished product in terms of its chemical, physical and biological characteristics.
118. In process control: Tests, Cheeks and measurements made during the course of manufacture that result and product will comply with its specification.
119. LAF: Laminar Air Flow is the flow of air currents in which streams do not intermingle the air moves along parallel flow lines, used in LAF hold to provide air free of microorganism over the work area. It can deliver clean air in vertical, horizontal direction. Movement of an entire body of air with in a confined area with uniform velocity along parallel flow lines without turbulence.
120. Class 100: Area where maximum no. of particles per cubic ft 0.5 μm and large much no exceed 100 is called class 100. Class 100 condition means that no more than 100 particles / ft3 of size 0.5 μm shall be found in that particular area detected by a electronic particle counter. Particle count not to exceed a lot of 100 particles per cubic feet of a size 0.5 μm and large size.
121.
DOP Test: Dioctyl Pthanate test is used to determine the integrity of
HEPA filters. The test uses a heterogeneous dioctylphthalate aerosol having the
following approximate light scattering mean droplet size 99%, less than 3.0 μm,
50% less than 0.7μm and 10% less than 0.4μm. The test is used to test the HEPA
filters for leaks. The DOP aerosols of 0.28 μms – 0.4 μms size are introduced
upstream of the filter and leaks are detected down stream with an aerosol
photometer. The aerosol is generated by a mechanical aerosol generator.
122. Optical Density: Optical density is the measure of the concentration of a solute in solution, obtained by measuring the degree to which the solution absorbs light of a particular wavelength. It can be used to measure the concentration of bacterial, proteins, DNA or RNA in solution. The optical density, d2020, of a substance is the ratio of the mass of a given volume of the substance to the mass of an equal volume of water bath weighed at 20°. The optical relative density is determined with precision indicated in the monograph. The optical density expressed in kgm-3, d2020, = 1.00180 × 10-3 p20
123. Optical Rotation: The optical rotation of a substance is the angle through which the plane of polarization is rotated, when polarized light is passed through a chemical substance, if liquid or solution of the substance, if solid substance are described as dextrorotatory or Levorotatory according to whether the plane of polarization is rotated „clock wise or anticlock wise‟, respectively as determined by viewing towards the light source . Dextrorotation is designated (+) and Levorotation is designated (-). The optical rotation, α, unless other wise specified, is measured at the wavelength of the sodium D line (589.3 nm) at a temperature of 20° in a layer 1 dm thick determine the angle of rotation of the substance being examined at 19.5° to 20.5°. So rotation of a plane of polarized light by a chemical compound clock wise (+) or counter clock wise (-) with respect to a light source. The optical rotation determination is a method for the measurement of the angular rotation of the sample using a polarimeter.
124. UV Sterilization: Ultraviolet light sterilization is used mainly to sterilize heat sensitive materials and products and to reduce microbial load in air, pure water or surface within processing environment. The germicidal light is emitted at wave length of 2537 Aº and the effectiveness is dependent on the intensity of radiation & time of exposure. To kill micro-organism by ultra violet rotation. UV radiation at 254 – 256 nm is the bacterial effect.
125. Fumigation: Fumigation is the process to reduce microbial load in a particular area by using KMnO4 or HCHO fumes for specified time. To kill micro-organism by 40% formaldehyde fumigation at 60% RH. The use of poisonous fumes or gases to destroy living organisms. Fumigants are relatively ineffective against bacteria and viruses. To make smoke which is used in disinfeeting a room. Fumigate substance such as formation used to produces fumes which are lethal to insects & rodents.
122. Optical Density: Optical density is the measure of the concentration of a solute in solution, obtained by measuring the degree to which the solution absorbs light of a particular wavelength. It can be used to measure the concentration of bacterial, proteins, DNA or RNA in solution. The optical density, d2020, of a substance is the ratio of the mass of a given volume of the substance to the mass of an equal volume of water bath weighed at 20°. The optical relative density is determined with precision indicated in the monograph. The optical density expressed in kgm-3, d2020, = 1.00180 × 10-3 p20
123. Optical Rotation: The optical rotation of a substance is the angle through which the plane of polarization is rotated, when polarized light is passed through a chemical substance, if liquid or solution of the substance, if solid substance are described as dextrorotatory or Levorotatory according to whether the plane of polarization is rotated „clock wise or anticlock wise‟, respectively as determined by viewing towards the light source . Dextrorotation is designated (+) and Levorotation is designated (-). The optical rotation, α, unless other wise specified, is measured at the wavelength of the sodium D line (589.3 nm) at a temperature of 20° in a layer 1 dm thick determine the angle of rotation of the substance being examined at 19.5° to 20.5°. So rotation of a plane of polarized light by a chemical compound clock wise (+) or counter clock wise (-) with respect to a light source. The optical rotation determination is a method for the measurement of the angular rotation of the sample using a polarimeter.
124. UV Sterilization: Ultraviolet light sterilization is used mainly to sterilize heat sensitive materials and products and to reduce microbial load in air, pure water or surface within processing environment. The germicidal light is emitted at wave length of 2537 Aº and the effectiveness is dependent on the intensity of radiation & time of exposure. To kill micro-organism by ultra violet rotation. UV radiation at 254 – 256 nm is the bacterial effect.
125. Fumigation: Fumigation is the process to reduce microbial load in a particular area by using KMnO4 or HCHO fumes for specified time. To kill micro-organism by 40% formaldehyde fumigation at 60% RH. The use of poisonous fumes or gases to destroy living organisms. Fumigants are relatively ineffective against bacteria and viruses. To make smoke which is used in disinfeeting a room. Fumigate substance such as formation used to produces fumes which are lethal to insects & rodents.
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126. Depyrogenation: To kill pyrogen by heating at 200º C - 250º C is called Depyrogenation. It is the process in which dry heat at 250º C for 30 minutes or 200º C for
1
hour is used to remove pyrogens from equipment‟s
and containers used for sterile product. Time is also a factor for killing
pyrogens.
127. Sensitivity: Sensitivity is the capacity of the test procedure to record small variation in concentration. It is the slope of the calibration curve. A more general use of term to encompass limit of detection and or limit of quantitation should be avoided. The limit of detection is the lowest detectable quantity at the most sensitive instrument setting.
128. Limit of Quantitation: the limit of quantitation is the lowest concentration of analyte in a sample that may be determined with acceptable accuracy and precession when the required procedure is applied. It is measured by analyzing samples containing known quality of the analyte and determining the lowest level at which acceptable degree of accuracy & precession are attainable. In many cases the limit of quantitation is approximately twice the limit of detection. Concentration below the minimum quantifiable limit (MQL) should not be used in data interpretation. Standard curves should not be extrapolated below MQL.
129. CFU: Colony Forming Units. Colony Forming Units are the no. of microbes that can replicate of form colors . Multiplication of bacterium on a solid surface results in the formation of colony visible to the necked eye. It takes generally 16 – 24 hours.
130. Dehumidification: It is the process to reduce the humidity of a particular area using a dehumidifier. A dehumidifier is a unit, which absorbs the moisture content of the air. The function of dehumidifier is to remove moisture in the vapor state from an air stream. After moisture has been removed the air stream then may contact a product to be direct or may be used as a mass of air entering a space where humidity control is needed.
131. WFI: Water for injection is intended to a high degree of chemical purity and to be free from pyrogenic substances and endotoxin. It is prepared by distillation or reverse osmosis. It must be clear, colorless and odorless having pH within the range of 5.0 to 7.0. Water for injection is a water for the preparation of medicines for parenteral administration, when water is used as a vehicle and for dissolving or diluting substance or preparation for parenteral administration. Water for injection is a pyrogenic distilled water.
132. DM Water: DM Water stands for Deminaralized water. The water free from materials is called Deminaralized water. Deminaralized water are purified water from which the minerals are removed by ion exchange method. It is clean liquid, colorless and tasteless.
133. Potable Water: Potable water is dunking water, treated by the local authority or an site, is suitable for human consumption. Water which are free of pathogens and toxic substances, odorless, i.e. in a state safe for drinking and other use are called potable water. It is generally used for tape water or the water which drink is must meet pharmacopoeia requirement.
127. Sensitivity: Sensitivity is the capacity of the test procedure to record small variation in concentration. It is the slope of the calibration curve. A more general use of term to encompass limit of detection and or limit of quantitation should be avoided. The limit of detection is the lowest detectable quantity at the most sensitive instrument setting.
128. Limit of Quantitation: the limit of quantitation is the lowest concentration of analyte in a sample that may be determined with acceptable accuracy and precession when the required procedure is applied. It is measured by analyzing samples containing known quality of the analyte and determining the lowest level at which acceptable degree of accuracy & precession are attainable. In many cases the limit of quantitation is approximately twice the limit of detection. Concentration below the minimum quantifiable limit (MQL) should not be used in data interpretation. Standard curves should not be extrapolated below MQL.
129. CFU: Colony Forming Units. Colony Forming Units are the no. of microbes that can replicate of form colors . Multiplication of bacterium on a solid surface results in the formation of colony visible to the necked eye. It takes generally 16 – 24 hours.
130. Dehumidification: It is the process to reduce the humidity of a particular area using a dehumidifier. A dehumidifier is a unit, which absorbs the moisture content of the air. The function of dehumidifier is to remove moisture in the vapor state from an air stream. After moisture has been removed the air stream then may contact a product to be direct or may be used as a mass of air entering a space where humidity control is needed.
131. WFI: Water for injection is intended to a high degree of chemical purity and to be free from pyrogenic substances and endotoxin. It is prepared by distillation or reverse osmosis. It must be clear, colorless and odorless having pH within the range of 5.0 to 7.0. Water for injection is a water for the preparation of medicines for parenteral administration, when water is used as a vehicle and for dissolving or diluting substance or preparation for parenteral administration. Water for injection is a pyrogenic distilled water.
132. DM Water: DM Water stands for Deminaralized water. The water free from materials is called Deminaralized water. Deminaralized water are purified water from which the minerals are removed by ion exchange method. It is clean liquid, colorless and tasteless.
133. Potable Water: Potable water is dunking water, treated by the local authority or an site, is suitable for human consumption. Water which are free of pathogens and toxic substances, odorless, i.e. in a state safe for drinking and other use are called potable water. It is generally used for tape water or the water which drink is must meet pharmacopoeia requirement.
134.
Conductivity: Conductivity is an electrolytic conductance and the
conducting compounds are electrolytes. Acid Bases and Salts conduct
electricity. Conductivity is the electric conducting ability of a substance. It
is the ability of metals to conduct electric current. In case of chemical
compound, it is the ability to conduct electricity by virtue ion present.
Measuring electrical resistance and calculating conductivity, which is the
reciprocal of the resistance, determine conductivity. Its unit Ohm/cm.
135. Annual Review – An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures
135. Annual Review – An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures
136. CAPA – Corrective and preventive action: A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of potential nonconforming product and other quality problems (preventive action)
137. Laminar Flow Hood Environment for preparation of sterile products within a streamline flow near a solid boundary
138. Continual Improvement – Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness
139. Correction – Repair, rework, or adjustment relating to the disposition of an existing discrepancy
140. Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence
141. Customer – A person or organization (internal or external) that receives a product or service anywhere along the product‟s life cycle
142. Discrepancy – Datum or result outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend
143. Harm – Damage to health, including the damage that can occur from the loss of product quality or availability
144. Non-conformity – A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements
145. Preventive Action – Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence
146. Product/Service – The intended results of activities or processes; products/services can be tangible or intangible
147.
Quality – A measure of a product or service‟s ability to satisfy the customer‟s stated or implied needs
148. Quality Assurance – Proactive and retrospective activities that provide confidence that requirements are fulfilled
149. Quality Control – The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible
150. Quality Management – Accountability for the successful implementation of the quality system
151. Quality Objectives – Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy
152. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization
148. Quality Assurance – Proactive and retrospective activities that provide confidence that requirements are fulfilled
149. Quality Control – The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible
150. Quality Management – Accountability for the successful implementation of the quality system
151. Quality Objectives – Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy
152. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization
153. Quality Planning – A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives
154. Quality Policy – A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.
155. Quality System – Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement
156. Quality Unit – A group organized within an organization to promote quality in general practice
157. Risk – The combination of the probability of occurrence of harm and the severity of that harm
158. Risk Assessment – A
systematic process for organizing information to support a risk decision that
is made within a risk management process. The process consists of the
identification
of hazards and the analysis and evaluation of risks associated with exposure to
those hazards.
159. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk
160. Senior Management – Top management officials in a firm who have the authority and responsibility to mobilize resources
161. Stakeholder – An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements
162. Verification – Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
159. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk
160. Senior Management – Top management officials in a firm who have the authority and responsibility to mobilize resources
161. Stakeholder – An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements
162. Verification – Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
163.
Validation – Validation is a documented evidence
which provides a high degree of assurance that a specific process, method or
system will consistently produce to the required specification in accordance
with accepted standards of cGMP.
164. Active pharmaceutical ingredient (API) - Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
165. Contamination - The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, or intermediate or finished product during production, sampling, packaging or repackaging, storage or transport.
166. Cross-contamination - Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
167. Expiry date - The date given on the individual container (usually on the label) of a drug product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
168. Labelling - The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.
169. Manufacture - All operations of purchase of materials and products, production, quality control, release, storage and distribution of finished products, and the related controls.
170. Material - A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling materials.
171. Packaging material - Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
172. Pharmaceutical product - Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.
164. Active pharmaceutical ingredient (API) - Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
165. Contamination - The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, or intermediate or finished product during production, sampling, packaging or repackaging, storage or transport.
166. Cross-contamination - Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
167. Expiry date - The date given on the individual container (usually on the label) of a drug product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
168. Labelling - The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.
169. Manufacture - All operations of purchase of materials and products, production, quality control, release, storage and distribution of finished products, and the related controls.
170. Material - A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labelling materials.
171. Packaging material - Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
172. Pharmaceutical product - Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.
173. Production - All
operations involved in the preparation of a pharmaceutical product, from
receipt of materials, through processing, packaging and repackaging, labelling
and relabelling, to completion of the finished product.
174. Retest date - The date when a material should be re-examined to ensure that it is still suitable for use.
175. Storage - The storing of pharmaceutical products and materials up to their point of use.
176. Supplier - A person providing pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be authorized by a competent authority.
177. Calibration (old) The performance of tests and retests to ensure that measuring equipment (e.g. for temperature, weight, pH) used in a manufacturing process or analytical procedure (in production or quality control) gives measurements that are correct within established limits.
178. Calibration (new) The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
179. Computer validation Documented evidence, which provides a high degree of assurance that a computerized system records data correctly and that data processing complies with, predetermined specifications.
180. Concurrent validation Validation carried out during routine production of products intended for sale.
181. Cleaning validation Documented evidence to ensure that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration i.e. batch size, dosing, toxicology, equipment size, etc.
182. Design Qualification (DQ) Documented evidence that the premises, supporting utilities, equipment and processes have been designed in accordance with the requirements of GMP.
183. Good Engineering Practices MY HOPE PORTAL – HUB OF PHARMACEUTICAL EMPLOYMENT
174. Retest date - The date when a material should be re-examined to ensure that it is still suitable for use.
175. Storage - The storing of pharmaceutical products and materials up to their point of use.
176. Supplier - A person providing pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be authorized by a competent authority.
177. Calibration (old) The performance of tests and retests to ensure that measuring equipment (e.g. for temperature, weight, pH) used in a manufacturing process or analytical procedure (in production or quality control) gives measurements that are correct within established limits.
178. Calibration (new) The set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring (especially weighing), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. Limits for acceptance of the results of measuring should be established.
179. Computer validation Documented evidence, which provides a high degree of assurance that a computerized system records data correctly and that data processing complies with, predetermined specifications.
180. Concurrent validation Validation carried out during routine production of products intended for sale.
181. Cleaning validation Documented evidence to ensure that cleaning procedures are removing residues to predetermined levels of acceptability, taking into consideration i.e. batch size, dosing, toxicology, equipment size, etc.
182. Design Qualification (DQ) Documented evidence that the premises, supporting utilities, equipment and processes have been designed in accordance with the requirements of GMP.
183. Good Engineering Practices MY HOPE PORTAL – HUB OF PHARMACEUTICAL EMPLOYMENT
Established
engineering methods and standards that are applied throughout the project lifecycle
to deliver appropriate, cost-effective solutions.
184. Installation Qualification (IQ)(old) IQ is the documentary evidence to verify that the equipment has been built and installed in compliance with design specifications.
185. Installation Qualification (IQ)(new) The performance of tests to ensure that the installations (such as machines, measuring devices, utilities, manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
186. D value- The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.
187. Operational Qualification (OQ)(old) OQ is the documentary evidence to verify that the equipment operates in accordance with its design specifications in its normal operating range and performs as intended throughout all anticipated operating ranges.
188. Operational Qualification (OQ)(new) Documented verification that the system or subsystem performs as intended over all anticipated operating ranges.
189. Performance Qualification (PQ) PQ is the documentary evidence, which verifies that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods. (The term “process validation” may also be used.)
190. Process validation (See Validation) Documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
191. Prospective validation Validation carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps; these are then evaluated on the basis of past experience to determine whether they may lead to critical situations.
184. Installation Qualification (IQ)(old) IQ is the documentary evidence to verify that the equipment has been built and installed in compliance with design specifications.
185. Installation Qualification (IQ)(new) The performance of tests to ensure that the installations (such as machines, measuring devices, utilities, manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.
186. D value- The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.
187. Operational Qualification (OQ)(old) OQ is the documentary evidence to verify that the equipment operates in accordance with its design specifications in its normal operating range and performs as intended throughout all anticipated operating ranges.
188. Operational Qualification (OQ)(new) Documented verification that the system or subsystem performs as intended over all anticipated operating ranges.
189. Performance Qualification (PQ) PQ is the documentary evidence, which verifies that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods. (The term “process validation” may also be used.)
190. Process validation (See Validation) Documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics.
191. Prospective validation Validation carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps; these are then evaluated on the basis of past experience to determine whether they may lead to critical situations.
192. Qualification (new) Action of proving and documenting that any premises, systems and equipment are properly installed, and/or work correctly and lead to the expected results. Qualification is often a part (Initial stage) of Validation, but the individual qualification steps alone do not constitute process validation.
193. Retrospective validation MY HOPE PORTAL – HUB OF PHARMACEUTICAL EMPLOYMENT Thanks
Involves
the examination of past experience of production on the assumption that
composition, procedures, and equipment remain unchanged.
194. Revalidation (old) Involves the repeat of the initial process validation to provide assurance that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.
195. Revalidation (new) Repeated validation of an approved process (or a part thereof) to ensure continued compliance with established requirements.
196. Standard operating procedure (SOP) An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature [new] (e.g. equipment Working document QAS/03.055/Rev.2 operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.
194. Revalidation (old) Involves the repeat of the initial process validation to provide assurance that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.
195. Revalidation (new) Repeated validation of an approved process (or a part thereof) to ensure continued compliance with established requirements.
196. Standard operating procedure (SOP) An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more general nature [new] (e.g. equipment Working document QAS/03.055/Rev.2 operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product-specific master and batch production documentation.
197. Validation (new) Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
198. Validation Protocol (VP)(old) The VP is a written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment and decision points on what constitutes acceptable test results.
199. Validation Protocol (or plan) (VP)(new) A document describing the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process - or a part thereof - for routine use.
200. Validation Report (VR)(old) The VR is a written report on the validation activities, the validation data and the conclusions drawn.
201. Validation Report (VR)(new) A document in which the records, results and evaluation of a completed validation programmed is assembled. It may also contain proposals for the improvement of processes and/or equipment.
202. Validation Master Plan (VMP)
VMP is a high level document that
establishes an umbrella validation plan for the entire project and summarizes
the manufacturer‟s overall philosophy and approach, to be
used
for establishing performance adequacy. It provides information on the
manufacturer‟s validation work programmed and defines details of and
time-scales for the validation work to be performed, including stating the
responsibilities relating to the plan.
203. Verification The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the GMP principles.
204. Worst case A condition or set of conditions encompassing upper and lower processing limits and circumstances, within SOPs, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily include product or process failure.
205. Air lock- A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing airlock is to preclude ingress of particulate matter and microorganism contamination from a lesser-controlled area.
206. Alert Level- An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels.
207. Action Level- An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.
208. Aseptic Manufacturing Area- The classified part of a facility that includes the aseptic processing room and ancillary clean rooms. For purposes of this document, this term is synonymous with “aseptic processing facility” as used in the segregated segment context.
209. Aseptic Processing Facility- A building, or segregated segment of it, containing clean rooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.
210. Aseptic Processing Room- A room in which one or more aseptic activities or processes is performed.
211. Asepsis- A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product.
203. Verification The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the GMP principles.
204. Worst case A condition or set of conditions encompassing upper and lower processing limits and circumstances, within SOPs, which pose the greatest chance of product or process failure when compared to ideal conditions. Such conditions do not necessarily include product or process failure.
205. Air lock- A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing airlock is to preclude ingress of particulate matter and microorganism contamination from a lesser-controlled area.
206. Alert Level- An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels.
207. Action Level- An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.
208. Aseptic Manufacturing Area- The classified part of a facility that includes the aseptic processing room and ancillary clean rooms. For purposes of this document, this term is synonymous with “aseptic processing facility” as used in the segregated segment context.
209. Aseptic Processing Facility- A building, or segregated segment of it, containing clean rooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.
210. Aseptic Processing Room- A room in which one or more aseptic activities or processes is performed.
211. Asepsis- A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product.
212.
Bioburden- The total number of microorganisms associated with a specific
item prior to sterilization.
213. Barrier- A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area.
214. Biological Indicator (BI)- A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.
215. Clean Area- An area with defined particle and microbiological cleanliness standards.
216. Clean room- A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.
217. Component- Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.
218. Colony Forming Unit (CFU)- A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. One colony-forming unit is expressed as 1 CFU.
219. Critical Area – An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas.
221. Critical surfaces- Surfaces that may come into contact with or directly affect a sterilized product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing.
222. Decontamination- A process that eliminates viable Bioburden via use of sporicidal chemical agents.
223. Disinfection- Process by which surface Bioburden is reduced to a safe level or eliminated. Some Disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores.
224. Depyrogenation- A process used to destroy or remove pyrogens (e.g., endotoxin).
226. Dynamic- Conditions relating to clean area classification under conditions of normal production.
227. Endotoxin- A Pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death Gowning Qualification- A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.
228. HEPA filter- High efficiency particulate air filters with minimum 0.3 μm particle retaining efficiency of 99.97 percent.
229. HVAC- Heating, ventilation, and air conditioning.
230. Intervention- An aseptic manipulation or activity that occurs at the critical area.
231. Isolator- A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). There are two major types of isolators: Closed isolator systems exclude external contamination from the isolator‟s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations. Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.
232. Laminar flow- An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight-line vector.
233. Operator- Any individual
participating in the aseptic processing operation, including line set-up,
filler, maintenance, or other personnel associated with aseptic line
activities.Overkill
sterilization process- A process that is sufficient to provide at least a 12
log reduction of microorganisms having a minimum D value of 1 minute.
234. Pyrogens- A substance that induces a febrile reaction in a patient.
235. Sterile Product- For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.
236. Sterilizing grade filter- A filter that, when appropriately validated, will remove all microorganisms from a fluid stream, producing a sterile effluent.
237. Quality Control Unit- An organizational element with authority and responsibility as defined by 211.22.
238. Unidirectional flow- An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.
239. Terminal sterilization- The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a no sterile unit of greater than one in a million).
240. ULPA filter- Ultra-low penetration air filter with minimum 0.3 μm particle retaining efficiency of 99.999 percent.
241. Validation- Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. or Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
234. Pyrogens- A substance that induces a febrile reaction in a patient.
235. Sterile Product- For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.
236. Sterilizing grade filter- A filter that, when appropriately validated, will remove all microorganisms from a fluid stream, producing a sterile effluent.
237. Quality Control Unit- An organizational element with authority and responsibility as defined by 211.22.
238. Unidirectional flow- An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.
239. Terminal sterilization- The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a no sterile unit of greater than one in a million).
240. ULPA filter- Ultra-low penetration air filter with minimum 0.3 μm particle retaining efficiency of 99.999 percent.
241. Validation- Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. or Validation is a documented evidence which provides a high degree of assurance that a specific process, method or system will consistently produce to the required specification in accordance with accepted standards of cGMP.
242.
Bioavailability The amount of a drug that reaches its intended
destination by being absorbed into the bloodstream
243. Bioequivalence The difference between a drug that is manufactured ina different dosage form or by a different company; includes the rate if absorption, distribution, metabolism, and excretion 244. Distribution The ability of a drug to passs into the bloodstream
245. Excretion The process of elimination of medicinal agents
246. Half-life The amount of time required for a chemical to be decreased by one half
247. OTC Over-the-counter medications that do not require a prescription
248. Monograph The description of a drug, including side effects, dosage forms, indications, and oteh pertinent information
249. Pharmacokinetics The life of a drug, which includes absorption, metabolism, distribution, and excretion
250. Chemical Structure The shape of molecules and their location with regard to one another
251. Brand/trade Name Trademark of a drug or device created by the original manufacturer
252. Horizontal Flow Hood Environement for preparation of sterile products that uses air originating fromthe back of the hood moving forward across the hood out into the room
253. Hyperalimentation Parenteral nutrition for individuals unable to eat
254. Aromatic waters = clear, saturated solutions of volatile oils or other aromatic substances in water. They are used orally, topically, or pharmaceutically for the characteristics of the aromatic material they contain.
255. Peripheral Parenterals Injection of a medication into the veins on the periphery of the body instead of into a central vein or artery
243. Bioequivalence The difference between a drug that is manufactured ina different dosage form or by a different company; includes the rate if absorption, distribution, metabolism, and excretion 244. Distribution The ability of a drug to passs into the bloodstream
245. Excretion The process of elimination of medicinal agents
246. Half-life The amount of time required for a chemical to be decreased by one half
247. OTC Over-the-counter medications that do not require a prescription
248. Monograph The description of a drug, including side effects, dosage forms, indications, and oteh pertinent information
249. Pharmacokinetics The life of a drug, which includes absorption, metabolism, distribution, and excretion
250. Chemical Structure The shape of molecules and their location with regard to one another
251. Brand/trade Name Trademark of a drug or device created by the original manufacturer
252. Horizontal Flow Hood Environement for preparation of sterile products that uses air originating fromthe back of the hood moving forward across the hood out into the room
253. Hyperalimentation Parenteral nutrition for individuals unable to eat
254. Aromatic waters = clear, saturated solutions of volatile oils or other aromatic substances in water. They are used orally, topically, or pharmaceutically for the characteristics of the aromatic material they contain.
255. Peripheral Parenterals Injection of a medication into the veins on the periphery of the body instead of into a central vein or artery
256.
Gauge The size of a needle opening
257. Tablets = solid dosage forms containing one or more medicinal substances with or without added pharmaceutical ingredients. Among the pharmaceutical agents used are diluents, disintegrants, colorants, binders, solubilizers, and coatings.
258. Pharmacist Person who dispenses drugs and counsels patients
259. RX Latin for "recipe"; commonly used to mean "prescription"
260.Capping:- „Capping‟ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
261. Laminating:- „Lamination‟ is the separation of a tablet into two or more distinct horizontal layers.
262. Sticking/filming: „ Sticking‟ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
263. Cracking:- Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
264. Chipping:- „ Chipping‟ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
265. Mottling:‘ Mottling‟ is the term used to describe an unequal distribution of colour on a tablet. 267. Double Impression: „ Double impression‟ involves only those punches,which have a monogram or other engraving on them.
257. Tablets = solid dosage forms containing one or more medicinal substances with or without added pharmaceutical ingredients. Among the pharmaceutical agents used are diluents, disintegrants, colorants, binders, solubilizers, and coatings.
258. Pharmacist Person who dispenses drugs and counsels patients
259. RX Latin for "recipe"; commonly used to mean "prescription"
260.Capping:- „Capping‟ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
261. Laminating:- „Lamination‟ is the separation of a tablet into two or more distinct horizontal layers.
262. Sticking/filming: „ Sticking‟ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
263. Cracking:- Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
264. Chipping:- „ Chipping‟ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
265. Mottling:‘ Mottling‟ is the term used to describe an unequal distribution of colour on a tablet. 267. Double Impression: „ Double impression‟ involves only those punches,which have a monogram or other engraving on them.
266. What is the standard number of rotations used for friability test? A. 100 rotations
267. Q What is the fall height of the tablets in the friabilator during friability testing? A. 6 inches.Tablets falls from 6 inches height in each turn within the apparatus.
268. Q Which capsule is bigger in size - size '0' or size '1'? A. '0' size
269. Q. Which type of tablets are exempted from Disintegration testing?
A.
Chewable Tablets
270. DEVIATION: \ Deviation is an unexpected event that occurs during the on-going operation / Activity / Documentation / Entries at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution of Drug Products / Intermediates / Raw Materials / Packing materials. Deviations are to be reported as and when they occur and to be investigated for impact assessment.
271. Critical Deviation: Deviation that could have significant impact on the product quality or GMP system. Examples of critical deviations are given below but not limited to:
Cross contamination or product mix up
in a product.
Failure to process step during
manufacturing.
Use of obsolete batch document / test
method.
Filter integrity failure.
272. Major
Deviations: Deviation that could have a moderate to
considerable impact on the product quality or GMP system. Examples of major
deviations are given below but not limited to:
Machine breakdown during processing
Mix ups of cartons of same product
with different strength.
273. Planned
Deviation: Planned deviations, which are
described, and pre-approved deviation from the current operational
document/system, covering a specified period of time or number of batches.
Planned deviation shall be approved before execution.
274. Unplanned Deviation: Unplanned deviations also called as incident. Incident can be defined as unplanned or un-controlled event in the form of non-compliance from the designed systems or procedures at any stage of manufacturing, packaging, sampling, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
275. CAUSES AND REMEDIES OF CAPPING RELATED TO „FORMULATION‟ (GRANULATION)?
274. Unplanned Deviation: Unplanned deviations also called as incident. Incident can be defined as unplanned or un-controlled event in the form of non-compliance from the designed systems or procedures at any stage of manufacturing, packaging, sampling, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.
275. CAUSES AND REMEDIES OF CAPPING RELATED TO „FORMULATION‟ (GRANULATION)?
276. THE CAUSES AND REMEDIES OF CAPPING RELATED TO „MACHINE‟ (DIES, PUNCHES AND TABLET PRESS)
277. Brief about ICH stabilty guidelines?
A.Q1A- Stability testing of new drug substance & products
Q1B- Photo stability testing of new drug substances & products
Q1C-Stability testing of new dosage forms
Q1D-Bracketing & Matrixing designs for testing of new drug substances and products
Q1E-Evaluation of stability data
Q1F-Stability data package for registration applications in climatic zone III & IV (Withdrawed)
278. How many Tablets shall be taken for checking friability? A. For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g.For tablets with unit mass more than 650mg,take a sample of 10 whole tablets.
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