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PHARMACEUTICAL INTERVIEW DESK
280- Short Question-Answer for ALL dept

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.
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.
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.
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.
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:
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.
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.
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.

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
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) (21CFR
137. 820.100)
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
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. (Reference: The ASQ Auditing Handbook,
3rd edition, ASQ Quality Audit Division, J.P. Russell, and Editor)

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.

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

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.
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

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.
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.

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).
225. 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.
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.

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. Laminar Flow Hood Environement for preparation of sterile products within a
streamline flow near a solid boundary
256. Peripheral Parenterals Injection of a medication into the veins on the periphery of
the body instead of into a central vein or artery

257. Gauge The size of a needle opening
258. 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.
259. Pharmacist Person who dispenses drugs and counsels patients
260. RX Latin for "recipe"; commonly used to mean "prescription"
261.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.
262. Laminating:- „Lamination‟ is the separation of a tablet into two or more distinct
horizontal layers.
263. 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.
264. 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.
265. Chipping:- „ Chipping‟ is defined as the breaking of tablet edges, while the tablet
leaves the press or during subsequent handling and coating operation.
266. 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.
268. What is the standard number of rotations used for friability test?
A. 100 rotations
269. 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.
270. Q Which capsule is bigger in size - size '0' or size '1'?

A. '0' size
271. Q. Which type of tablets are exempted from Disintegration testing?

A. Chewable Tablets
272. 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.
273. 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.
274. 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.
275. 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.
276. 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.
277. CAUSES AND REMEDIES OF CAPPING RELATED TO „FORMULATION‟ (GRANULATION)?

Sr.
CAUSES REMEDIES
No.
Large amount of fines in the Remove some or all fines through 100 to 200
1.
granulation mesh screen
Too dry or very low moisture Moisten the granules suitably. Add hygroscopic
2. content (leading to loss of substance e.g.: sorbitol, methyl- cellulose or PEG-
proper binding action). 4000.
3. Not thoroughly dried granules. Dry the granules properly.
Increasing the mount of binder OR
Insufficient amount of binder or Adding dry binder such as pre-gelatinized starch,
4.
improper binder. gum acacia, powdered sorbitol, PVP, hydrophilic
silica or powdered sugar.
Increase the amount of lubricant or change the
5. Insufficient or improper lubricant.
type of lubricant.
Granular mass too cold to
6. Compress at room temperature.
compress firm.
278.
THE CAUSES AND REMEDIES OF CAPPING RELATED TO „MACHINE‟ (DIES, PUNCHES AND
TABLET PRESS)
Sr.
CAUSES REMEDIES
No.
Polish dies properly. Investigate other
1. Poorly finished dies
steels or other materials.
Deep concave punches or beveled-
2. Use flat punches.
edge faces of punches.
Lower punch remains below the face of Make proper setting of lower punch
3.
die during ejection. during ejection.
Incorrect adjustment of sweep-off Adjust sweep-off blade correctly to
4.
blade. facilitate proper ejection.
Reduce speed of turret (Increase dwell
5. High turret speed.
time).
279. 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)
280. 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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MY HOPE PORTAL – HUB OF PHARMACEUTICAL EMPLOYMENT

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PHARMACEUTICAL INTERVIEW DESK

280- Short Question-Answer for ALL dept

2. Segregation: Segregation means separating or setting apart. It is the process to

3. Ambient Temperature: Ambient temperature means the temperature surround us. In

4. Cold/Cool Temperature: A temperature range between 2º C – 8º C is called cool

6. Control Condition Temperature: The temperature between 20ºC – 25ºC is known as

7. Batch: A defined quantity of starting material, packaging material or product

8. Batch no.: A distinctive combination of numbers and/or letters which specifically

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16. In Process Materials: In process material means any material fabricated

22. Representative Sample: Representative Sample means a sample that consists of a

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24. Revalidation: Revalidation means the repetition of the validation process or a

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34. Precessions: Precession defines the closeness of agreement between a series of

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laboratories conducting the same test. Precession is usually expressed as a standard

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36. Reproducibility: Reproducibility expresses the precession between laboratories. It

37. Robustness: Robustness of an analytical procedure is a measure of its capacity to

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40. Regeneration System: Regeneration means the regaining of previous condition. It

41. Manufacturing: The complete set of activities to produce a drug comprising of

42. Reprocessing: The reworking of all or part of batch of product of an unacceptable

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excluding packaging information. A document or set of documents specifying the

49. Accelerated S. Study: A test performed to determine the rate of degradation of

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D P = Bubble point pressure K = Shape correction factor D = Pore diameter γ = Surface

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73. Endotoxin: Bacterial Endotoxin or pyrogen is metabolic products of living micro-

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81. Depyrogenation Temperature: Depyrogen means free from Pyrogen an a parenteral

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87. Preservative Deactivation Test: In pharmaceutical preservative is commonly used to

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packaged in containers holding 100 ml or more. It is commonly used to refer to injection

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100. Suspension: A suspension is a preparation of finely divided undissolved drugs,

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102. Suppository: Suppositories are solid preparation intended to insertion in to the

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115. Master Formula: Documents used in pharmaceutical manufacturing generally

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