pharmaceutics

1. A
Accelerated testing: Studies designed to increase the rate of chemical degradation or
physical change of a drug substance or drug product by using exaggerated storage conditions
as part of the formal stability studies. Data from these studies, in addition to long term
stability studies, can be used to assess longer term chemical effects at non-accelerated
conditions and to evaluate the effect of short term excursions outside the label storage
conditions such as might occur during shipping. Results from accelerated testing studies are
not always predictive of physical changes.
Acceptance criteria: Numerical limits, ranges, or other suitable measures for acceptance of
the results of analytical procedures.
Accuracy: The accuracy of an analytical procedure expresses the closeness of agreement
between the value which is accepted either as a conventional true value or an accepted
reference value and the value found.This is sometimes termed trueness.
Active Ingredient: An Active Pharmaceutical Ingredient (API) is the chemical substance
contained in a pharmaceutical, which is responsible for its therapeutic effect.
Active Substance Master File (ASMF)/Drug Master File (DMF) : is a document
containing complete information on an Active Pharmaceutical Ingredient (API) or finished
drugdosage form. It is known as European Drug Master File (EDMF) or Active Substance
Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States
respectively.
Aerobic Microorganism: A microorganism that utilizes oxygen as the final electron
acceptor during metabolism: a microorganism that will grow primarily in the presence of
Oxygen.
Aerosol:Air suspension of solid or liquid particles having a volume mediandiameter of less than 50 µm.
The small size of the droplets or particles allows entry to the body via the respiratory tract and readily
contaminates clothing,skin and eyes
Agglomeration: Adherence of particles in to a larger mass due to moisture, static charge or
chemical or mechanical binding.
Aggregation: Accumulation or collection of particles in to larger units.
Glossary

2. Amorphous: Solid substances that are not crystals.
Analgesic: A medication that reduces or eliminates pain.
Angle of repose: Angle of repose is the greatest angle form the horizontal that a heap of
material will remain stationary.
Analytical Procedure: The analytical procedure refers to the way of performing the analysis.
It should describe in detail the steps necessary to perform each analytical test. This may
include but is not limited to: the sample, the reference standard and the reagents preparations,
use of the apparatus, generation of the calibration curve, use of the formulae for the
calculation, etc.
Anemometer: Anemometer is an instrument used to measure air flow velocity.
Antacid: An agent that counteracts or neutralizes acidity.
Antiemetics: Drugs used to treat nausea & Vomiting.
Anti flatulent: Any agent that reduces intestinal gas.
Antineoplastics: Drugs used to treat cancer.
Antipyretic: A medication that reduces body temperature or pain.
Anaerobic Organism: A microorganism that does not utilize oxygen as the final electron
acceptor during metabolism:microorganism that will grow only in the absence of Oxygen.
Analyte: Substance for which analysis is being performed.
Annual Product Quality Review (APQR): APQR is overall review of the product
manufactured during the whole calendar year , for all the parameters including critical
parameters and trend of the batches .
1. ANDA: An application to market a generic drug in the USA. The application does not contain
extensive preclinical (pharmacology & toxicology) or clinical data. Instead an ANDA for a
typical tablet or capsule relies on therapeutic equivalence to the innovator product (or
reference listed product), together with an extensive CMC section.
Aseptic Filling: The part of aseptic processing where a pre sterilized product is filled and / or
packed in to sterile containers and closed.
Aseptic Processing: Handling sterile materials in a controlled environment, in which the air
supply, facility, materials, equipment and personnel are regulated to control microbial and

3. particulate contamination to acceptable levels.
Aseptic Process Simulation: A means for establishing the capability of an aseptic process as
performed using a growth medium.
Note: Aseptic processing simulations are understood to be synonymous with media fills,
process simulations, simulated product fills, broth trials, broth fills etc.
At-rest: Condition where the installation is complete with equipment installed and operating
in a manner agreed upon by the customer and supplier, but with no personnel present.
B
Bar code: A way of labelling a product with a description and batch information using a
series of lines of various thickness that is read by a scanner.
Batch (or Lot): A specific quantity of material produced in a process or series of processes
so that it is expected to be homogeneous within specified limits. In the case of continuous
production, a batch may correspond to a defined fraction of the production. The batch size
can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
BET: A toxin that forms an integral part of the cell wall of certain bacteria and is only
released upon destruction of the bacterial cell. Endotoxins are less potent and less specific
than most exotoxins and do not form toxoids. Also calledintracellular toxin.
Binder:An excipient used to increase powder cohesiveness,which increases the bonding
strength of the final product.In wet granulation, they help to formagglomerates.
Binding: Difficulty in ejection of tablets from a die after compression. Binding is evident as
excessive ejection force, and it can sometimes be heard as a “sqeaking” noise during
tableting. In extreme cases binding can result in tablet lamination. Increase in the amount of
lubricant (magnesium stearate or talc) is a potential solution, as is proper maintenance and
polishing of the dies. If this is not feasible then coated or tapered dies are available that can
reduce the friction during ejection.
Bioavailability: A measure of the fraction of a drug that enters the systemic blood circulation
after oral administration. The usual measure is the ratio of the AUC of two different
formulations of the same drug, corrected for dose.
Bioburden: The level and type (e.g. objectionable or not) of micro-organisms that can be

4. present in raw materials, API starting materials, intermediates or APIs. Bioburden should not
be considered contamination unless the levels have been exceeded or defined objectionable
organisms have been detected.
Bioequivalence: A high degree of similarity in the bioavailabilities of two pharmaceutical
products (of the same galenic form) from the same molar dose, that are unlikely to produce
clinically relevant differences in therapeutic effects, or adverse effects, or both
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.
Biopharmaceutical Classification System (BCS): A system of classification of drugs based
on their solubility and their permeability through the gut wall. The system was introduced by
Professor Gordon Amidon in 1995. A soluble drug is one whose highest dose is soluble in
250ml or less of aqueous media over the pH range 1 to 7,5. A permeable drug is one that is
more than 90% absorbed from the human gut. Permeability may be determined using in vitro
model systems. The BCS classes are Class 1: high solubility & high permeability. Class 2 =
low solubility & high permeability. Class 3 = High solubility & low permeability. Class 4 =
low solubility & low permeability.
Biosimilar: Biosimilar is a version of an already registered biological medicine that has a
demonstrable similarity in physicochemical, biological and immunological characteristics,
efficacy and safety, based on comprehensive comparability studies.
Biowaiver: An exemption from the need to perform a clinical bioequivalence study under
certain circumstances. Biowaivers are possible in the USA, in Europe and in Japan, but the
requirements for achieving a biowaiver differ in these countries. In the USA and Europe the
biowaiver is potentially available for rapidly dissolving formulations of BCS class 1 drugs.
Blending: Process of mixing the ingredients together to form a uniform mixture. Blending in
solid dose manufacturing has two objectives; 1) To achieve blend uniformity and 2) to
distribute the lubricant.
Blister: A cavity formed in film or foil by heat and or chemical means.

5. Blister Pack: A package that comprises one or more blisters filled with tablets or capsules
and sealed with film or foil lid stock.
Blow Fill Seal (BFS): Blow-fill-seal (BFS) technology is an automated process by which
containers are formed, filled, and sealed in a continuous operation. This manufacturing
technology includes economies in container closure processing and reduced human
intervention and is often used for filling and packaging ophthalmics, respiratory care
products, and, less frequently, injectables.
Boroscope: An instrument used to view unseen places such as internal weld finishes in an
enclosed pipe work system.
Body: the lower part of a two piece capsule. It is slightly smaller in diameter and longer than
cap.
Body fold: An imperfection in the capsule body caused by depositing material on it during
filling.
Bovine: Originating from cattle, used to describe gelatine made from cattle products.
Bovine Spongiform Encephalopathy: A disease of cattle (often called 'mad cow disease')
caused by an agent that is neither a bacterium nor a virus.BSE is a fatal neurodegenerative
disease which affects mainly the brain and spinal chord.
Bowie Dick Test: A test which used to detect air leaks and inadequate air removal in pre-
vacuum type sterilizers.
Bracketing: The design of a stability schedule such that only samples on the extremes of
certain design factors, e.g., strength, package size, are tested at all time points as in a full
design. The design assumes that the stability of any intermediate levels is represented by the
stability of the extremes tested. Where a range of strengths is to be tested, bracketing is
applicable if the strengths are identical or very closely related in composition (e.g., for a
tablet range made with different compression weights of a similar basic granulation, or a
capsule range made by filling different plug fill weights of the same basic composition into
different size capsule shells). Bracketing can be applied to different container sizes or
different fills in the same container closure system.
Bronchodilators: Drugs that open up the bronchial tubes within the lungs when the tubes
have become narrowed by muscle spasm. Bronchodilators ease breathing in diseases such as

6. asthma.
Brittleness: The extent to which a material will break without undergoing significant elastic
or plastic deformation.
Bubble Point Test: Bubble point is a practical non destructive test used for confirming the
integrity of sterilizing membrane filters and filter systems.
Bulk Density: The mass per unit volume of a material under specified conditions of pressure.
Bulk Product : Any product which has completed all processing stages up to, but not
including, final packaging.
Bursting strength: Pressure at which a film or sheet (ofpaper or plastic, for example) will
burst. Used as a measureof resistance to rupture, burst strength depends largely on the tensile
strength and extensibility of the material.
C
Calibration: The demonstration that a particular instrument or device produces results within
specified limits by comparison with those produced by a reference or traceable standard over
an appropriate range of measurements.
Cap: The upper part of a two piece capsule. It is slightly larger in diameter and shorter than
the body.
CAPA (corrective and preventive action): A systematic approach that includes actions
needed to correct (correction), avoid recurrence (corrective action) and eliminate the cause of
potential nonconforming product and other quality problems (preventive action).
Caplet: A tablet shaped like a capsule to ease swallowing.
Capping: A fault in tablet making. In capping the top of the tablet separates from the rest of
the tablet. Capping may be apparent as the tablet is ejected from the die, or occur at some
subsequent stage in tablet processing, for example during coating or friability testing, or at
any other time when the tablet is stressed. Capping is usually explained in terms of air
entrapment in a tablet or in terms or stress relaxation during decompression. The cures
include increasing the compression dwell time (slowing the machine or adding
precompression), decreasing the compaction force applied or increasing the binding within
the tablet. Fractures that occur between the tablet cup and the band due to poor particle
adhesion, over compression and or insufficient air release during compaction.

7. CBE (CBE & CBE 30 day Supplement):
Change-Being-Effected Supplement (CBE) - A submission to an approved application
reporting changes that FDA has identified as having moderate potential to adversely affect
the identity, strength, quality, purity, or potency of a product as they may relate to the safety
or effectiveness of the product. A CBE supplement must be received by FDA before or
concurrently with distribution of the product made using the change.
Change-Being-Effected-in-30-Days Supplement (CBE-30)- A submission to an approved
application reporting changes that FDA has identified as having moderate potential to
adversely affect the identity, strength, quality, purity, or potency of a product as they may
relate to the safety or effectiveness of the product. A CBE- 30 supplement must be received
by FDA at least 30 days before distribution of the product made using the change.
CEP: CEP stands for Certification of suitability of European Pharmacopoeia monographs.
COS (“Certificate of Suitability”) means the same and, even if often used, is not the official
acronym.
Change Control: Change control is a procedure that ensures changes are implemented in a
controlled and coordinated manner. A change control system provides checks and balances in
the quality system by tracking, reviewing and approving the changes.
Change Management: A systematic approach to proposing, evaluating, approving,
implementing and reviewing changes
Change Over: The process of changing production from one product to another. This often
includes clearing the production area of supplies and components, changing size – specific
machine parts, and cleaning the production area and equipment to eliminate cross
contamination.
Chemistry, manufacturing and controls (CMC): The section of an ANDA or NDA where
all the data on synthetic chemistry, impurities, formulation, manufacturing, packaging,
specifications, analytical methods and stability are submitted.
Child Resistant Packaging : Child resistant packaging is a special type of packaging used to
reduce the risk of children ingesting dangerous items. This is often accomplished by the use
of a special safety cap.

8. Chipping: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the
press or during subsequent handling and coating operations.
Classified Area: An area in which the environment is of specified particulate and microbial
quality. These areas are monitored to ensure that microbial articulate qualities are
maintained. The four types of classified area’s are as defined in European Good
Manufacturing Practices.
Grade A: The local zone for high risk operations.
Grade B: In the case of aseptic preparation and filling, the
Background environment for Grade A areas.
Grade C: Clean, controlled, support areas for carrying out less critical stages of
manufacturing.
Grade D: Clean, controlled, support areas for carrying out less critical stages of
manufacturing.
Clean area (clean room):An area (or room) with defined environmental control of
particulate and microbial contamination, constructed and used in such a way as to reduce the
introduction, generation and retention of contaminants within the area.
Clean Hold Time: The time from the end of a cleaning process until the equipment is used
again.
Clean in place (CIP): A method of cleansing all contaminants from the interior surfaces of
process equipment without dissembling it.
Cleaning Validation: A process giving evidence that the cleaning operation can consistently
meet predetermined standards.
Climatic zones: The four zones in the world that are distinguished by their characteristic
prevalent annual climatic conditions. This is based on the concept described by W. Grimm
(Drugs Made in Germany, 28:196-202, 1985 and 29:39-47, 1986).
Closed Joined Length: The length of a hard elatine capsule after it has been filled and
completely closed by a capsule filling machine. Most capsules have a lock that makes than
difficult to open after they have been closed to this length.
Coating: The process of applying a coat to a tablet or other dosage form. Coatings are

9. applied for a number of reasons from aesthetic (colour, identification and ease of handling or
swallowing) to highly functional (delayed and modified release). Aesthetic coatings are
typically based on low viscosity grades of HPMC or PVA, whereas functional coatings are
typically based on methacrylic acid copolymers or cellulose derivatives such as
ethylcellulose.
Code of federal regulations (CFR): CFR is the codification of the general and permanent
rules and regulations.CFR can be called as administrative law and is published by federal
government of united states.
Cold Forming: Cold forming is a technique that does not involve any application of heat.
Unlike the thermoformingmethod that uses clear PVC, this technique uses thin sheets of
laminate film that contain aluminum. In order to create packaging out of these sheets, a
blister machine will typically use a stamp to force it into a form. The aluminum-based film
will tend to stretch and retain the shape after the stamp has been removed. This type of blister
pack is typically used to contain pharmaceuticals, since the aluminum-based film tends to
prevent moisture from entering the packaging.
Colony Forming unit (CFU): A microbiological term which describes the formation of a
single macroscopic colony after introduction of one (or more) microorganism(s) to
microbiological growth media. One colony forming unit is expressed as 1 CFU.
Conductivity: Conductivity is the ability of a material to pass an electric current. Since the
charge on ions in solution facilitates the conductance of electrical current, the conductivity of
the solution is proportional to its ion concentration.
Container closure system: The sum of packaging components that together contain and
protect the dosage form. This includes primary packaging components and secondary
packaging components, if the latter are intended to provide additional protection to the drug
product. A packaging system is equivalent to a container closure system.
Combination product: A drug product which contains more than one drug substance.
Compounding: A process in which a bulk drug substance is combined with one or more
excipients and/or another bulk substance to produce a bulk product.
Compression: The process of reducing the bulk volume of a material by applying external

10. force.
Compression Mix: The powder processed into tablets on a tablet machine. A compression
mix may be made by wet granulation, dry granulation, simple blending or any other suitable
technique.
Concurrent Validation: Validation carried out during routine production of products
intended for sale.
Contamination: The undesired introduction of impurities of a chemical or microbiological
nature, or of foreign matter, into or onto a raw material, intermediate, or API during
production, sampling, packaging or repackaging, storage or transport.
Critical Area: Area where sterilized products or containers/closures are exposed to the
environment (i.e aseptic preparation and filling).
Critical Process Parameter (CPP): A process parameter whose variability has an impact on
a critical quality attribute and therefore should be monitored or controlled to ensure the
process produces the desired quality.
Critical Quality Attribute (CQA): A physical, chemical, biological or microbiological
property or characteristic that should be within an appropriate limit, range, or distribution to
ensure the desired product quality.
Cross-Contamination: Contamination of a material or product with another material or
product.
Concurrent Validation: Validation carried out during routine production of products
intended for sale.
Corrective Action: Action to eliminate the cause of a detected non-conformity or other
undesirable situation. NOTE: Corrective action is taken to prevent recurrence whereas
preventive action is taken to prevent occurrence. (ISO 9000:2005)
COS: A certificate provided to the manufacturer by the European Directorate for the Quality
of Medicines & HealthCare to certify that the relevant monograph in the European
Pharmacopoeia adequately controls the substance as manufactured by the company at the
time the certificate was granted.
Counterfeit Medicine: The term counterfeit medical product describes a product with a false

11. representation of its identity and/or Source. This applies to the product, its container or other
packaging or labelling information. Counterfeits may include products with correct
ingredients/components, with wrong ingredients/components, without active ingredients, with
incorrect amounts of active ingredients, or with fake packaging. Violations or disputes
concerning patents must not be confused with counterfeiting of medical products.
CTD: A harmonised layout for the structure and content of application dossiers applicable to
the USA, the European Union and Japan. The CTD has 5 modules of which module 3
(Quality) contains the chemical and pharmaceutical section of the dossier.
D
D Value : Decimal reduction value (for biological indicators).The time in minutes required to
secure inactivation of 90% (one log) of the test organisms under stated exposure conditions.
Decongestants: Drugs that reduce swelling of the mucous membranes, that line the nose by
contracting blood vessels, thus relieving nasal stuffiness.
Deduster: A piece of equipment that removes flashing and dust from solid dosage forms. It is
often combined with a metal detector and installed at the oulet of a tablet press or capsule
filler.
Degradation Product: An impurity resulting from a chemical change in the drug substance
brought about over time and/or by the action of e.g., light, temperature, pH, water, or by
reaction with an excipient and/or the immediate container/closure system. Also called
decomposition product.
Delayed Release: A drug product (typically oral) that is not intended to release the drug
substance immediately after ingestion. The delay is commonly related to change of pH in the
gastrointestinal tract (“enteric coating”) or less commonly may relate to a specific time after
ingestion when the drug is released. Enteric coating is achieved by coating with polymers that
are poorly soluble in low pH media (for example gastric fluid), but are soluble in media with
pH values typically found lower in the intestine. Methacrylic acid copolymers are very
commonly used for delayed release coatings as they can be supplied in grades that dissolve at
different pH values.
Desiccant: A highly hygroscopic substance used to absorb moisture in bottles,vials,blisters
and other packing.
Design qualification (DQ):The documented verification that the proposed design of the

12. facilities, systems and
equipment is suitable for the intended purpose.
Depyrogenation: A process used to destroy or remove pyrogens.
Detection Limit: The detection limit of an individual analytical procedure is the lowest
amount of analyte in a sample which can be detected but not necessarily quantitated as an
exact value.
Deviation: Departure from an approved instruction or established standard.
Die: A circular machine tool with a central cavity in which powders or granular solids are
compacted in to tablet between the upper and lower punches of a tablet press.
Diluent: A component of a tablet or capsule, usually present to add bulk to the dosage form.
The most commonly used diluents include lactose, microcrystalline cellulose and native or
pregelatinised starches. Dibasic calcium phosphate and mannitol are also used.
Direct Compression: A means of producing a tablet without granulation. The active
ingredient is blended with excipients, typically at least a filler-binder, a disintegrant and a
lubricant and then the blend is compressed on a tablet machine. The filler-binders are usually
special grades of excipients (for example spray dried lactose) exhibiting good flow and
compaction properties to enable the DC process.
Dirty Hold time: The time from the end of product manufacturing until the beginning of the
cleaning process.
Disintegrant: An excipient that facilitates the disintegration of a tablet or other dosage form
in contact with water or gastro-intestinal fluid. Traditionally starch was used, but in general
today’s formulations utilise a so called superdisintegrant such as croscarmellose sodium or
sodium starch glycolate. Superdisintegrants are typically cross-linked hydrophilic polymers
that strongly attract water. The presence of the cross links allows swelling, but prevents
dissolution of the polymer and generation of high viscosity gels.
Disintegration: The process by which a solid oral dosage form breaks up in water when
measured in a standard apparatus.
Dissolution: The process by which drug dissolves out of a dosage form and is made available
for absorption from the gastro-intestinal tract. In vitro measurements are made in a range of
apparatus types. The requirements for different types of dosage forms are given in each

13. pharmacopoeia.
Diuretics: Drugs that increase the quantity of urine produced by kidney.
Dosage form: A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that
contains a drug substance generally, but not necessarily, in association with excipients.
DOP Test: Dioctyl Phthalate test is a test which used to check the HEPA filter integrity.
Drug master file (DMF): A DMF is a means of providing data on a processing facility, drug
substance, packaging material or excipient confidentially to FDA. The data in a DMF can be
accessed by FDA in support of an NDA upon provision of a letter of access (a letter from the
DMF holder to the NDA applicant authorising FDA to access the DMF during their review of
a particular NDA). In Europe there is no DMF system for excipients and in Japan there is a
recently introduced system.
Drug product: The dosage form in the final immediate packaging intended for marketing.
Drug substance: The unformulated drug substance that may subsequently be formulated
with excipients to produce the dosage form.
Dry granulation: A means of granulation (size enlargement) of a powder using a
compaction step followed by milling. The most common means of dry granulation in
pharmaceutical industry is roller compaction, although the older process of slugging is still
sometimes used. Anhydrous lactose is the most suitable form of lactose for these processes
because it tends to retain compactability after the dry granulation process.
E
Enantiomeric Impurity: A compound with the same molecular formula as the drug
substance that differs in the spatial arrangement of atoms within the molecule and is a non-
superimposable mirror image.
Endotoxin: A pyrogen (eg:lipopolysaccharide) derived from the cell wall of gram negative
bacteria. Endotoxin can lead to reactions in patients receiving injections ranging from fever to
death.
Enteric Coat: A delayed release coating, usually designed to delay release of the drug from
the dosage form until it has reached an area of the gastro-intestinal tract of a specified pH.

14. Methacrylic acid copolymers are very commonly used.
Equipment Train: The sequence of equipment through which a product is produced or
processed.
Environmental monitoring Program: Defined documented program which describes the
routine particulate and microbiological monitoring of processing and manufacturing areas.
Excipient: A component of a drug product other than the API, that is intentionally added to
the dosage form to enable processing into patient friendly medicines, to control the rate at
which the API dissolves from the dosage form, to aid drug stability and other reasons. For
solid oral dosage forms, main classes of excipients include diluents or filler-binders,
disintegrants, glidants, lubricants, coating materials, and stabilising agents.
Exotoxin: An exotoxin is a toxin secreted by bacteria. An exotoxin can cause damage to the
host by destroying cells or disrupting normal cellular metabolism. They are highly potent and
can cause major damage to the host. Exotoxins may be secreted, or, similar to endotoxins,
may be released duringlysis of the cell.
Expectorant: Drugs that stimulate the flow of saliva and promotes coughing to eliminate
phlegm from the respiratory tract.
Expiration date: The date placed on the container label of a drug product designating the
time prior to which a batch of the product is expected to remain within the approved shelf life
specification if stored under defined conditions, and after which it must not be used
Extended Release: A form of modified release dosage form in which the dissolution rate of
the drug from a medicine is controlled over an extended period of time, usually to reduce the
frequency at which a patient has to take the medicine. A number of means of effecting
extended release are possible, the most common being barrier coating (with for example
acrylate polymers), inclusion of hydrogel polymers (for example hydroxypropyl methyl
cellulose) and construction of osmotic pumps.
Extractable: Extractables are chemical entities, both organic and inorganic, that will extract
from components of a container closure system or device into solvents under controlled
conditions.

15. F
Factory Acceptance Test (FAT):Factory acceptance test is test conducted at the vendors
premises, to verify that the equipment/system operates according to the specifications.
Finished product : Finished product is a product that has undergone all stages of production,
including packaging in its final container and labelling.
Fixed Dose Combination(FDC): Fixed Dose Combinations (FDCs) refer to products
containing two or more active ingredients used for a particular indication(s).
Flashing: Small extrusions that appear around tablet periphery where the band meets the
cups. It usually flakes off during handling, dedusting or coating.
Fluid-bed dryer (FBD): A device that dries powder using mechanical force and/or airflow to
evaluate and aerate it, increasing interstitial particle spacing and driving off moisture.
Fluid bed granulation: The process of spraying solution onto aerated powders to form
granules.
Foil: Thin-gauge aluminium, usually 20 to 25 microns thick, that can be used as blister
material,push-through lidstock,or backing when combined with film or paper.
Forced Degradation : Forced degradation testing studies are those undertaken to degrade the
sample deliberately. These studies, which may be undertaken in the development phase
normally on the drug substances, are used to evaluate the overall photosensitivity of the
material for method development purposes and/or degradation pathway elucidation.
Form FDA 483: A form of observations usually produced after an FDA inspection of a drug
development or drug manufacturing facility. Only significant deviations from cGMP are
listed and thus 483 observations are only negative.
Formulation: An ingredient or mixture of specific ingredients; that is, drug substances and
excipients in specific amounts, defining a given product.
Friabilty: A measure of the resistance to abrasion and breakage of tablets during a
standardised test involving tumbling tablets in a rotating drum. Details of the equipment and
test protocol are found in all main pharmacopoeia. A limit of not more than 1% weight loss is
generally taken to be a satisfactory measure of friability.
G
Generic Drug: A drug for which the patents protecting the originator product have expired

16. (or may be challenged). Generic products are pharmaceutically equivalent to a reference
listed drug (same drug substance, same route of administration, same dosage form and same
strengths) and are also therapeutically equivalent (typically bioequivalent for oral solid
dosage forms).
Genetically modified organism (GMO):
A genetically Modified Organism is
1. an organism that has been modified by gene technology; or
2. an organism that has inherited particular traits from an organism (the initial organism), being
traits that occurred in the initial organism because of gene technology; or
3. anything declared by the regulations to be a genetically modified organism, or that belongs to a
class of things declared by the regulations to be genetically modified organisms.
Glidants: Glidants are execipients used to promote powder flow by reducing inter particle
friction and cohesion. These are used in combination with lubricants as they have no ability
to reduce die wall friction (ex: talc).
Gowning Qualification: Program which establishes,both initially and on periodical basis,the
capability of an individual to done the complete sterile gown in aseptic manner.
Granulation: Granulation is the process in which primary powder particles are made to
adhere to form larger, multi particle entities called granules. Granulation process is an
inevitable step in tablet manufacturing as it improves flow property and compressibility of
powder mass intended for compression.
Growth Promotion Test: Test performed to demonstrate the ability of the microbial media
to support microbial growth.
H
HEPA Filter : High efficiency particulate air filter with minimum 0.3 micron particle
retaining efficiency of 99.97%.
Hygroscopicity: A material’s ability to absorb moisture from its surroundings.
I
ICH: International Conference on Harmonization.
Immediate (primary) pack: is that constituent of the packaging that is in direct contact with
the drug substance or drug product, and includes any appropriate label.

17. Impermeable containers: Containers that provide a permanent barrier to the passage of
gases or solvents, e.g., sealed labelling tubes for semi-solids, sealed glass ampoules for
solutions.
Immediate Release: Allows the drug to dissolve in the gastrointestinal contents, with no
intention of delaying or prolonging the dissolution or absorption of the drug.
Impurity: Any component of the new drug substance that is not the chemical entity defined
as the new drug substance.
Intermediate precision: Intermediate precision expresses within-laboratories variations:
different days, different analysts, different equipment, etc.
Intermediate Product: Partially processed product that must undergo further manufacturing
steps before it becomes bulk product.
Intermediate testing: Studies conducted at 30°C/65% RH and designed to moderately
increase the rate of chemical degradation or physical changes for a drug substance or drug
product intended to be stored long term at 25°C.
In-process tests: Tests which may be performed during the manufacture of either the drug
substance or drug product, rather than as part of the formal battery of tests which are
conducted prior to release.
Installation Qualification (IQ): The documented verification that the facilities, systems and
equipment, as installed or modified, comply with the approved design and the manufacturer’s
recommendations.
Intervention: Aseptic manipulations or activity performed by a personnel that occurs within
the critical area.
Investigation new drug application (INDA) – It is an application which is filed with FDA
to get approval for legally testing an experimental drug on human subjects in the USA.
L
Lamination: The presence of weak planes in a compressed tablet normal to the direction of
compaction. On subsequent handling or processing it is possible for the tablet to separate into
layers along these weak planes. Lamination may have the same causes as capping, or it may
also be a result of under lubrication of the tablet compression mix.
Laxatives: Laxatives (purgatives, aperients) are foods,compounds and/or drugs that facilitate

18. or increase bowel movements. They are most often used to treat constipation.
LD50: The dose of a material which results in 50% mortality in an animal test.
Leachable: Leachables are chemical entities, both organic and inorganic, that migrate from
components of a container closure system or device into a drug product over the course of its
shelf-life.
Lidstock: Material used to seal blisters to prevent or minimize moisture and/or gas
permeation.
Line Clearence: Line clearance includes a careful examination of the area and equipment
before batch to batch or product to product change over to avoid cross contamination.
Linearity: The linearity of an analytical procedure is its ability (within a given range) to
obtain test results which are directly proportional to the concentration (amount) of analyte in
the sample.
Long term testing: Stability studies under the recommended storage condition for the re-test
period or shelf life proposed (or approved) for labelling.
Lubricant: An excipient that is used in tablet and capsule formulations to allow ejection of
the compressed tablet from the die, or the capsule plug from the dosator. Lubricants also act
as anti-adherents to prevent sticking of the tablet to the tablet punches during compression.
By far the most commonly used lubricant is magnesium stearate, although less hydrophobic
materials such as sodium stearyl fumarate are now available. Other lubricants include
calcium stearate and mixtures of talc and stearic acid. Options to minimise the need for tablet
lubrication include the use of coated punches in compression and tablet machine
developments that add very small quantities of lubricants directly to the punches during
tableting.
Lyophilization: A process by which material is rapidly frozen and dehydrated under high
vacuum.
M
Marketing authorisation application (MAA): is an application (to the relevant authority ;
typically the UK’s MHRA or the European Commission’s Committee for Medicinal Products
for Human Use (CHMP) to market a drug or medicine. The U.S. Food and Drug

19. Administration equivalent of Marketing authorisation application (MAA) is a New Drug
Application(NDA).
Marketing Pack: Marketing pack is the combination of immediate pack and other secondary
packaging such as a carton.
Mass balance: The process of adding together the assay value and levels of degradation
products to see how closely these add up to 100% of the initial value, with due consideration
of the margin of analytical error.
Matrixing: The design of a stability schedule such that a selected subset of the total number
of possible samples for all factor combinations is tested at a specified time point. At a
subsequent time point, another subset of samples for all factor combinations is tested. The
design assumes that the stability of each subset of samples tested represents the stability of all
samples at a given time point. The differences in the samples for the same drug product
should be identified as, for example, covering different batches, different strengths, different
sizes of the same container closure system, and, possibly in some cases, different container
closure systems.
Mean kinetic temperature: A single derived temperature that, if maintained over a defined
period of time, affords the same thermal challenge to a drug substance or drug product as
would be experienced over a range of both higher and lower temperatures for an equivalent
defined period. The mean kinetic temperature is higher than the arithmetic mean temperature
and takes into account the Arrhenius equation. When establishing the mean kinetic
temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927-929,
1971) can be used.
Media Fill – A “media fill” (sometimes known as a “process simulation”) is the performance
of an aseptic manufacturing procedure using a sterile microbiological growth medium in
place of the drug solution. Microbiological growth medium is used in place of the drug
solution during media fills to test whether the aseptic procedures are adequate to prevent
contamination during actual drug production. A media fill is one part of the validation of an
aseptic manufacturing process.
Milling: The process of de-agglomerating or reducing the particle size of powders manually
or by machine.

20. Modified Release: Dosage forms whose drug-release characteristics of time course and/or
location are chosen to accomplish therapeutic or convenience objectives not offered by
conventional dosage forms such as a solution or an immediate release dosage form. Modified
release solid oral dosage forms include both delayed and extended release drug products.
Moisture vapour transmission rate (MVTR): The amount of humidity that passes through
packaging film or foil over a unit of time and under specific environmental conditions.
Mottling: ‘Mottling’ is the term used to describe an unequal distribution of colour on a
tablet, with light or dark spots standing out in an otherwise uniform surface.
N
New Drug Application (NDA): The process by which a pharmaceutical company requests
permission to manufacture and sell a new drug in the USA. The NDA differs from the ANDA
in that it contains extensive data on safety and efficacy of the proposed new drug.
New molecular entity: An active pharmaceutical substance not previously contained in any
drug product registered with the national or regional authority concerned. A new salt, ester,
or non-covalent-bond derivative of an approved drug substance is considered a new
molecular entity for the purpose of stability testing under this guidance.
Non Condensable Gas: Gases which cannot be liquefied by compressron under the range of
conditions of temperature and pressure used during the operating cycle.
Non viable: A term used in reference to particulates, which are not capable of living,
growing or developing and functioning successfully –“unable to divide”
O
Operational Qualification (OQ):The documented verification that the facilities, systems
and equipment, as installed or modified, perform as intended throughout the anticipated
operating ranges.
Orally Disintegrating Tablet (ODI): An ODT is a dosage form designed to disintegrate or
dissolve quickly in the mouth without the need for water and without chewing. In general the
tablet should disintegrate within 30 seconds when tested using standard pharmacopoeial
disintegration apparatus, or another correlated disintegration test method.
Orange Book: “The Orange Book" is actually the U.S. Food and Drug Administration's

21. (FDA) official listing of Approved Drug Products with Therapeutic Equivalences. “Orange
book” is published by the FDA's Centre for Drug Evaluation and Research (CDER).
Orange Guide: “Orange guide” is published by MHRA. “Orange guide” contains the
requirements of Good Manufacturing Practice (It contains EU guidance on good
manufacturing and good distribution practice along with relevant information on EU and UK
legislation).
Orphan Drugs: "Orphan drugs" are medicinal products intended for diagnosis, prevention or
treatment of life-threatening or debilitating rare diseases. They are "orphans" because the
pharmaceutical industry has little interest under normal market conditions in developing and
marketing drugs intended for only a small number of patients suffering from very rare
conditions.
Out of specification (OOS): Test result that does not comply with the pre-determined
acceptance criteria (i.e. for example, filed applications, drug master files, approved marketing
submissions, or official compendia or internal acceptance criteria).
Out of trend (OOT): Is generally a stability result that does not follow the expected trend,
either in comparison with other stability batches or with respect to previous results collected
during a stability study. However the trends of starting materials and in-process samples may
also yield out of trend data.
Overage : Increased content of drug substance, usually due to loss of potency on storage.
Over Fill: Increased volume of drug product to account for loss during delivery.
Over the counter drugs (OTC): A drug product that is safe and effective for use without a
prescription.
Oxygen transmission rate (OTR): The amount of oxygen that passes through packaging
film or foil over a unit of time and under specific environmental conditions.
P
Paragraph 4 Filings: A type of ANDA submitted during the patent term of the originator
product. The filing asserts that either the patents supporting the originator product are invalid
or that they are not applicable to the product that is the subject of the ANDA.
Parametric Release: A sterility release system based upon effective control, monitoring,
documentation, and batch records review of a validated sterilization process cycle in lieu of

22. release procedures based upon end product sterility testing.
Performance Qualification (PQ): The documented verification that the facilities, systems
and equipment, as connected together, can perform effectively and reproducibly, based on the
approved process method and product specification.
Pharmacopoeia: Pharmacopoeia is a book or encyclopedia of Drugs Standards, their
formulas, Methods for making medicinal preparations and other related information's which
is published under the jurisdiction of government body.
Picking: A imperfection caused by powders sticking to a punch surface during tabletting.
Pilot scale batch: A batch of a drug substance or drug product manufactured by a procedure
fully representative of and simulating that to be applied to a full production scale batch. For
solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full
production scale or 100,000 tablets or capsules, whichever is the larger.
Pill Burden: Pill burden is a term that refers to the number of pills (tablets or capsules, the
most common dosage forms) that a patient takes on a regular basis.
Placebo: A product which stimulates the marketable product but has no active ingredient
present.
Polymorphic Forms: Different crystalline forms of the same drug substance. These can
include hydration products (also known as pseudo-polymorphs) and amorphous forms.
Potential Impurity: An impurity that theoretically can arise during manufacture or storage.
It may or may not actually appear in the new drug substance.
Precision: The precision of an analytical procedure expresses the closeness of agreement
(degree of scatter) between a series of measurements obtained from multiple sampling of the
same homogeneous sample under the prescribed conditions. Precision may be considered at
three levels: repeatability, intermediate precision and reproducibility.Precision should be
investigated using homogeneous, authentic samples. However, if it is not possible to obtain a
homogeneous sample it may be investigated using artificially prepared samples or a sample
solution.The precision of an analytical procedure is usually expressed as the variance,
standard deviation or coefficient of variation of a series of measurements.
Preventive Action: Action to eliminate the cause of a potential non-conformity or other

23. undesirable potential situation. NOTE: Preventive action is taken to prevent occurrence
whereas corrective action is taken to prevent recurrence. (ISO 9000:2005)
Primary batch: A batch of a drug substance or drug product used in a formal stability study,
from which stability data are submitted in a registration application for the purpose of
establishing a re-test period or shelf life, respectively. A primary batch of a drug substance
should be at least a pilot scale batch. For a drug product, two of the three batches should be
at least pilot scale batch, and the third batch can be smaller if it is representative with regard
to the critical manufacturing steps. However, a primary batch may be a production batch.
Probiotics: Probiotics are live microorganisms or microbial mixtures administered to
improve the patient's microbial balance, particularly the environment of the gastrointestinal
tract and the vagina.Probiotics have demonstrated an ability to prevent and treat some
infections.Probiotics can be bacteria,moulds or yeast.Commonly used bacterial strains are
Lactobacillus & Bifidobacterium.Commonly used yeast strain is Saccharomyces boulardii.
Process Analytical technology (PAT):A system for designing,analyzing and controlling
manufacturing through timely measurements critical quality and performance attributes of
raw and inprocess materials and processes with the goal of ensuring final product quality.
Process-Related Impurities: Impurities that are derived from the manufacturing
process. They may be derived from cell substrates (e.g., host cell proteins, host cell DNA),
cell culture (e.g., inducers, antibiotics, or media components), or downstream processing
(e.g., processing reagents or column leachables).
Product-Related Impurities: Molecular variants of the desired product (e.g., precursors,
certain degradation products arising during manufacture and/or storage) which do not have
properties comparable to those of the desired product with respect to activity, efficacy, and
safety.
Process Validation: The documented evidence that the process, operated within established
parameters, can
perform effectively and reproducibly to produce a medicinal product meeting its
predetermined specifications and quality attributes.
Production batch: A batch of a drug substance or drug product manufactured at production

24. scale by using production equipment in a production facility as specified in the application.
Pyrogen: Substance which induces febrile reactions in a patient.
Pure Steam: Steam whose condensate complies with the ompendia monograph, water for
injection (WFI).
Q
Quality Assurance (QA): The sum total of the organised arrangements made with the object
of ensuring that all APIs are of the quality required for their intended use and that quality
systems are maintained.
Quality by Design (QbD): A systematic approach to development that begins with
predefined objectives and emphasizes product and process understanding and process control,
based on sound science and quality risk management.
Qualification: Action of proving and documenting that equipment or ancillary systems are
properly installed, work correctly, and actually lead to the expected results. Qualification is
part of validation, but the individual qualification steps alone do not constitute process
validation.
Qualification Threshold: A limit above (>) which an impurity should be qualified.
Quality Manual: Document specifying the quality management system of an organisation.
(ISO 9000:2005)
Quality Risk Management: A systematic process for the assessment, control,
communication, and review of risks to the quality of the drug product across the product
lifecycle.
Quality System: The sum of all aspects of a system that implements quality policy and
ensures that quality objectives are met.
Quantitation Limit: The quantitation limit of an individual analytical procedure is the
lowest amount of analyte in a sample which can be quantitatively determined with suitable
precision and accuracy. The quantitation limit is a parameter of quantitative assays for low
levels of compounds in sample matrices, and is used particularly for the determination of

25. impurities and/or degradation products.
Quarantine: The status of materials isolated physically or by other effective means pending
a decision on their subsequent approval or rejection.
R
Range: The range of an analytical procedure is the interval between the upper and lower
concentration (amounts) of analyte in the sample (including these concentrations) for which it
has been demonstrated that the analytical procedure has a suitable level of precision, accuracy
and linearity.
Raw Material: A general term used to denote starting materials, reagents, and solvents
intended for use in the production of intermediates or APIs.
Recovery: The introduction of all or part of previous batches of the required quality into
another batch at a defined stage of manufacture.
Reconcilation: Comparing the total number of an item accounted for against the number or
quantity of the item at the beginning of the process to determine the difference (Comparison
between the theoretical quantity and the actual quantity).
Reference Listed Drug (RLD): The listed drug identified by FDA as the drug product upon
which an applicant relies in seeking approval of its ANDA. A generic drug must exhibit
therapeutic equivalence to the RLD.
Reference Standard, Primary: A substance that has been shown by an extensive set of
analytical tests to be authentic material that should be of high purity. This standard can be:
(1) obtained from an officially recognised source, or (2) prepared by independent synthesis,
or (3) obtained from existing production material of high purity, or (4) prepared by further
purification of existing production material.
Reference Standard, Secondary: A substance of established quality and purity, as shown by
comparison to a primary reference standard, used as a reference standard for routine
laboratory analysis.
Relative humidity : The ratio of the actual water vapour pressure of the air to the saturated
water vapour pressure of the air at the same temperature expressed as a percentage. More
simply put, it is the ratio of the mass of moisture in the air, relative to the mass at 100%

26. moisture saturation, at a given temperature.
Repeatability: Repeatability expresses the precision under the same operating conditions
over a short interval of time. Repeatability is also termed intra-assay precision .
Reprocessing: Introducing an intermediate or API, including one that does not conform to
standards or specifications, back into the process and repeating a crystallization step or other
appropriate chemical or physical manipulation steps (e.g., distillation, filtration,
chromatography, milling) that are part of the established manufacturing
process. Continuation of a process step after an in-process control test has shown that the
step is incomplete is considered to be part of the normal process, and not reprocessing.
Reproducibility: Reproducibility expresses the precision between laboratories (collaborative
studies, usually applied to standardization of methodology).
Residual Solvent: Residual solvents in pharmaceuticals are organic volatile chemicals that
are used or produced in the manufacture of drug substances or excipients, or in the
preparation of drug products.
Re-test date: The date after which samples of the drug substance should be examined to
ensure that the material is still in compliance with the specification and thus suitable for use
in the manufacture of a given drug product.
Re-test period: The period of time during which the drug substance is expected to remain
within its specification and, therefore, can be used in the manufacture of a given drug
product, provided that the drug substance has been stored under the defined conditions. After
this period, a batch of drug substance destined for use in the manufacture of a drug product
should be re-tested for compliance with the specification and then used immediately. A batch
of drug substance can be re-tested multiple times and a different portion of the batch used
after each re-test, as long as it continues to comply with the specification. For most
biotechnological/biological substances known to be labile, it is more appropriate to establish
a shelf life than a re-test period. The same may be true for certain antibiotics.
Retrospective Validation: Validation of a process for a product which has been marketed
based upon accumulated manufacturing, testing and control batch data.
Revalidation: Repeated validation of an approved process to ensure continued compliance
with established requirements.

27. Reworking: Subjecting an intermediate or API that does not conform to standards or
specifications to one or more processing steps that are different from the established
manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing
with a different solvent).
Risk Assessment: A systematic process of organizing information to support a risk decision
to be made within a risk management process. It consists of the identification of hazards and
the analysis and evaluation of risks associated with exposure to those hazards.
Risk Management: The systematic application of quality management policies, procedures,
and practices to the tasks of assessing, controlling, communicating, and reviewing risk
Robustness: The 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 usage.
Roller Compaction: A dry granulation process in which a powder blend is passed through
rollers under pressure to form a ribbon. The ribbon is milled into granules, optionally blended
with extra granular excipients and recompressed into tablets or filled into capsules.
S
Saturated steam: Steam whose temperature, at any given pressure, corresponds to that of the
vaporisation curve of water.
Scale Up: The process of converting a small volume process to large - volume production
Screening: The process of reducing agglomerates, sorting particles by size and removing
oversized particles and contaminants using a woven metal screen or perforated plate.
Semi-permeable containers: Containers that allow the passage of solvent, usually water,
while preventing solute loss. The mechanism for solvent transport occurs by absorption into
one container surface, diffusion through the bulk of the container material, and desorption
from the other surface. Transport is driven by a partial-pressure gradient. Examples of semi-
permeable containers include plastic bags and semi-rigid, low-density polyethylene (LDPE)
pouches for large volume parenterals (LVPs), and LDPE ampoules, bottles, and vials.
Shelf life (also referred to as expiration dating period):
The time period during which a drug product is expected to remain within the approved shelf
life specification, provided that it is stored under the conditions defined on the container

28. label.
Shingle: An effect caused by tablets stacking or backing up on the die table during the
ejection instead of them pushing each other of the tablet press.
Slugging: A form of dry granulation, somewhat similar to roller compaction. In slugging
however a powder blend is first compressed on a tablet machine and the resulting, usually
large, tablets (slugs) are milled, optionally reblended with more excipients, and recompressed
into tablets. Alternatively the milled slugs are sometimes filled into capsules.
Specification: A list of tests, references to analytical procedures, and appropriate acceptance
criteria which are numerical limits, ranges, or other criteria for the tests described. It
establishes the set of criteria to which a drug substance or drug product should conform to be
considered acceptable for its intended use. “Conformance to specifications” means that the
drug substance and / or drug product, when tested according to the listed analytical
procedures, will meet the listed acceptance criteria. Specifications are critical quality
standards that are proposed and justified by the manufacturer and approved by regulatory
authorities.
Specificity: Specificity is the ability to assess unequivocally the analyte in the presence of
components which may be expected to be present. Typically these might include impurities,
degradants, matrix, etc.Lack of specificity of an individual analytical procedure may be
compensated by other supporting analytical procedure(s).
This definition has the following implications:
entification: to ensure the identity of an analyte.
rity Tests: to ensure that all the analytical procedures performed allow an accurate statement of
the content of impurities of an analyte, i.e. related substances test, heavy metals, residual
solvents content, etc.
ssay (content or potency):
to provide an exact result which allows an accurate statement on the content or potency of
the analyte in a sample.
Specified Impurity: An impurity that is individually listed and limited with a specific

29. acceptance criterion in the new drug substance specification. A specified impurity can be
either identified or unidentified.
Spore: A bacterial form highly resistant to adverse conditions.
Stability: Ability of a material to maintain a stated property value within specified limits for
a specified period of time, when stored under specified conditions.
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, (e.g. equipment 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.
Starting Material: A material used in the synthesis of a new drug substance that is
incorporated as an element into the structure of an intermediate and/or of the new drug
substance. Starting materials are normally commercially available and of defined chemical
and physical properties and structure.
Sterile: Free of any viable organisms (Absence of life).
Sterility Assurance Level (SAL): Probability of a single viable microorganisms occurring in
an item.
Sterilization: A process used to render a product free of viable organisms with a specified
probability.
Sterilization in place (SIP): Sterilization in place or Steam in place (SIP) is a method used
to clean or disinfect process equipment and piping without disassembly. The SIP process can
be done manually or automated through the control system.
Sticking: Adhesion of a powder to the faces of a punch during tablet compaction. Causes are
various and include low melting components in a compression mix, inadequate drying of a
granulation, and inadequate lubrication of the compression mix. Additionally poor punch
maintenance can contribute to sticking. The remedies are generally evident from the causes,
but if low melting components cannot be excluded from a formulation then specially coated

30. tablet punches may be a solution. Occasionally changes to the punch design (for example
reducing the depth of concavity) may alleviate the problem.
Storage condition tolerances: The acceptable variations in temperature and relative
humidity of storage facilities for formal stability studies. The equipment should be capable of
controlling the storage condition within the ranges defined in this guideline. The actual
temperature and humidity (when controlled) should be monitored during stability storage.
Short term spikes due to opening of doors of the storage facility are accepted as unavoidable.
The effect of excursions due to equipment failure should be addressed, and reported if judged
to affect stability results. Excursions that exceed the defined tolerances for more than 24
hours should be described in the study report and their effect assessed.
Stress testing (drug substance): Studies undertaken to elucidate the intrinsic stability of the
drug substance. Such testing is part of the development strategy and is normally carried out
under more severe conditions than those used for accelerated testing.
Stress testing (drug product): Studies undertaken to assess the effect of severe conditions
on the drug product. Such studies include photostability testing (see ICH Q1B) and specific
testing on certain products, (e.g., metered dose inhalers, creams, emulsions, refrigerated
aqueous liquid products).
Super heated steam: Steam whose temperature, at a given pressure, is higher than that
indicated by the equilibration curve for the vaporization of water.
Supplement: A supplement is an application to allow a company to make changes in a
product that already has an approved new drug application (NDA). CDER must approve all
important NDA changes (in packaging or ingredients, for instance) to ensure the conditions
originally set for the product are still met.
Surfactant: A substance that decreases the surface tension of a liquid.
Sustained release: A method of drug delivery by which API release occurs over an extended
period after administration. The method reduces dosing frequency compared to a traditional
method such as immediate release.
T
Teratogenicity: The occurrence of structural malformations in a developing foetus when a

31. substance is administered during pregnancy.
Terminal sterilization: A process whereby product is sterilized with its sterile barrier
system.
Thermoforming: Thermoforming is a technique that involves heating sheets of PVC prior to
insertion into a blister machine. This is typically achieved by passing the sheets between
upper and lower heating plates. When a sheet enters a thermoforming blister machine, it is
soft and pliable and can be forced to take on the shape of a mold through the application of
pressure. In some cases, a mechanical stamp will be used in addition to the application of
pressure, particularly when the shape of the mold is difficult or complex.
Tincture: A medicine consisting of an extract in alcohol solution.
TOC: Total organic carbon (TOC) is the amount of carbonbound in an organic
compound and is often used as a non-specific indicator of water quality or cleanliness of
pharmaceutical manufacturing equipment.
Transmissible Spongiform Encephalopathy (TSE):TSE is a neurodegenerative
disorder caused by prions. Although these infections usually remain asymptomatic for years,
the disease is always progressive and fatal once the clinical signs develop.
Twininng: The bonding of tablets with large, flat surfaces during the coating process.
U
Uniformity of dosage Forms: A measure of the degree of uniformity of the amount of active
substance in individual dosage units (for example individual tablets or capsules). For
uncoated tablets, film coated tablets and hard capsules containing at least 25mg of drug
substance and the drug substance is at least 25% of the dosage form, then variation in weight
may be used as a measure of uniformity. For other solid oral dosage forms then individual
unit assays are necessary. Specific details are given in major pharmacopoeia.
Unidentified Impurity: An impurity for which a structural characterisation has not been
achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic
retention time).
Unspecified impurity: An impurity that is limited by a general acceptance criterion, but not
individually listed with its own specific acceptance criterion, in the new drug substance

32. specification.
Untitled letter: Untitled letter is issued by USFDA for violations that are not as significant
as those that trigger warning letters.
V
Validation: A documented program that provides a high degree of assurance that a specific
process, method, or system will consistently produce a result meeting pre-determined
acceptance criteria.
Validation Master Plan(VMP) - Validation master plan is a high-level document which
establishes an umbrella validation plan for the entire project, and is used as guidance by the
project team for resource and technical planning
Viable: Capable of living
Viscosity: The measurement of a materials resistance to flow.
W
Warning Letter: The Warning Letter is a document that usually originates from the FDA-
483 observations that have been linked to citations by one or more legal reviews within the
Compliance and legal branch of the FDA. Warning letters are issued for violations of
“regulatory significance”
Water for Injection (WFI): Water, which is intended for use in the preparations of
parenteral solutions.WFI is produced by distillation or a purification process that is
equivalent or superior to distillation in the removal of chemicals and microorganisms.
Wet Granulation: A means of granulation of powders using water or other liquid to
agglomerate powders into granules, and drying the granules. The process fixes API and
excipients into a granular form that helps to prevent segregation of the components, that aids
flow of there powders, and allows the incorporation of binders to improve compactability.
The granulation step and the drying step may be performed consecutively (typically using
high shear granulation and fluid bed drying) or concurrently (typically using fluid bed
granulation). Continuous wet granulation is increasingly being used to aid throughput in
pharmaceutical processing factories.
Y

33. Yield, Expected: The quantity of material or the percentage of theoretical yield anticipated
at any appropriate phase of production based on previous laboratory, pilot scale, or
manufacturing data.
Yield, Theoretical: The quantity that would be produced at any appropriate phase of
production, based upon the quantity of material to be used, in the absence of any loss or error
in actual production.
Z
Z- Value: The number of degrees of temperature change necessary to change the D-value by
factor of 10.