Glossary of Terms Version 04

This Glossary of Terms is based on the US Code of Federal Regulations (CFR), the EU Guidelines to
Good Manufacturing Practice Medicinal Products for Human and Veterinary Use (EU GMP Guide) and
on the GMP Guideline of the World Health Organisation (WHO).

Terms that are not explained there may derive from other sources (e.g. ICH ) or from more recent
literature.

Acceptance Criteria Means the product specifications and acceptance/rejection criteria, such as
acceptable quality level and unacceptable quality level, with an associated
sampling plan, that are necessary for making a decision to accept or reject
a lot or batch (or any other convenient subgroups of manufactured units).
(Code of Fed. Regulations/CFR)

Accuracy and precision In the context of the validation of a Rapid Microbiological Method accuracy
(qualitative method) and precision represents a direct method to show the equivalence of 2
qualitative methods. This is achieved by running them side by side and
determining the degree to which the method under evaluation shows
equivalence to the pharmacopoeial method. The accuracy and precision of
the alternative method may be expressed as the relative rates of false
positive and false negative results between the new method and the
pharmacopoeial method using a standardised, low-level inoculums.

Accuracy (quantitative In the context of the validation of a quantitative Rapid Microbiological

method) Method the accuracy is the closeness of the test results obtained by the
alternative method to the value obtained by the pharmacopoeial method.
Accuracy is usually expressed as the percentage of recovery of micro-
organisms by the method.

Act Means the Federal Food, Drug and Cosmetic Act, as amended. (Code of
Fed. Regulations/CFR)

Action Limit The action limit is reached when the acceptance criteria of a critical
parameter have been exceeded. Results outside these limits will require
specified action and investigation.
(WHO GMP)

Active Pharmaceutical A substance or compound that is intended to be used in the manufacture

Ingredient (API) of a pharmaceutical product as a pharmacologically active compound
(ingredient).
(WHO GMP)

Any substance or mixture of substances intended to be used in the

manufacture of a drug (medicinal) product and that, when used in the
production of a drug, becomes an active ingredient of the drug product.
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.
(EU GMP Guide, Part 2)

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Advanced Technology Any one of the following: A gene therapy medicinal product; a somatic cell
Medicinal Product therapy medicinal product; a tissue-engineered product.
(ATMP)

Adverse Drug Reaction All harmful and unintended responses to a medicinal product related to
(ADR) any dose.

Adverse Event (AE) Any improper medical occurrence in a patient administered a medicinal
product and which does not necessarily have a causal relationship with
this treatment. An adverse event (AE) can therefore be any unfavorable
and unintended sign (including an abnormal laboratory finding), symptom,
or disease temporally associated with the use of a medicinal
(investigational) product, whether or not related to the medicinal
(investigational) product.

Air Lock An enclosed space with two or more doors, and which is interposed
between two or more rooms, e.g. of differing class of cleanliness, for the
purpose of controlling the air-flow between those rooms when they need
to be entered. An air-lock is designed for and used by either people or
goods.
(EU GMP Guide)

Alert Limit The alert limit is reached when the normal operating range of a critical
parameter has been exceeded, indicating that corrective measures may
need to be taken to prevent the action limit being reached.
(WHO GMP).

Annual Product Review FDA requirement: Evaluation (at least annually) of the quality standards of
each drug product to determine the need for
changes in drug product specifications or manufacturing or control
procedures. Written procedures shall be established and followed for such
evaluations and shall include provisions for:
(1) A review of a representative number of batches, whether approved or
rejected, and, where applicable, records associated with the batch.
(2) A review of complaints, recalls, returned or salvaged drug products,
and investigations conducted under for each drug product.
(21 CFR 211.180(e))

API Starting Material A raw material, intermediate, or an API that is used in the production of
an API and that is incorporated as a significant structural fragment into
the structure of the API.
An API Starting Material can be an article of commerce, a material
purchased from one or more suppliers under contract or commercial
agreement, or produced in-house.
API Starting Materials are normally of defined chemical properties and
structure.
(EU GMP Guide)

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Aseptic Process A process using sterilized equipment before use, and which, in running
conditions, is protected against re-contamination by micro-organisms.
(EHEDG)

Audit An audit is a formal, independent, disciplined and objective review activity

designed to assess the performance of an operation, a set of operations, a
process or a system with regards to established regulations. In the field of
GMP it is generally accepted to classify audits in internal audits (inside the
same organisation), second party audits (between two contractants) and
third party audits (when using an independent auditor).

Batch (or Lot) Means a specific quantity of a drug or other material that is intended to
have uniform character and quality, within specified limits, and is
produced according to a single manufacturing order during the same cycle
of manufacture.
(FDA Code of Fed. Regulations)

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. (Note: to complete certain stages of
manufacture, it may be necessary to divide a batch into
a number of sub batches, which are later brought together to form a final
homogeneous batch. In the case of continuous manufacture, the batch
must correspond to a defined fraction of the production, characterised by
its intended homogeneity.
For control of the finished product, the following definition has been given
in Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC:
‘For the control of the finished product, a batch of a proprietary medicinal
product comprises all the units of a pharmaceutical form which are made
from the same initial mass of material and have undergone a single series
of manufacturing operations or a single sterilisation operation or, in the
case of a continuous production process, all the units manufactured in a
given period of time’.
(EU GMP Guide, Glossary)

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.
(EU GMP Guide, Part 2)

Batch Number A distinctive combination of numbers and/or letters which specifically

identifies a batch.
(EU GMP Guide, Glossary)

A unique combination of numbers, letters, and/or symbols that identifies a

batch (or lot) and from which the production and distribution history can
be determined.
(EU GMP Guide, Part 2)

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Batch Record All documents associated with the manufacture of a batch of bulk product
or finished product. They provide a history of each batch of product and of
all circumstances pertinent to the quality of the final product.
(WHO GMP)

Bioburden The total number of microorganisms associated with a specific item prior
to sterilization.
(FDA, Aseptic Guidance).

Biofilm A microbial consortium adhering to a surface.

(EHEDG)

Biogenerator A contained system, such as a fermenter, into which biological agents are
introduced along with other materials so as to effect their multiplication or
their production of other substances by reaction with the other materials.
Biogenerators are generally fitted with devices for regulation, control,
connection, material addition and material withdrawal.
(EU GMP Guide)

Biologic Active A material originating from a biological manufacturing process intended to

Pharmaceutical furnish pharmacological activity or other direct effect in the cure,
Ingredient treatment, or prevention of disease or conditions of human beings.
(FDA API Guide)

Biologic Product Any virus, therapeutic serum, toxin, antitoxin, or analogous product
applicable to the prevention, treatment, or cure of diseases or conditions
of human beings.
(FDA API Guide)

Biological Agents Micro-organisms, including genetically engineered micro-organisms, cell

cultures and endoparasites, whether pathogenic or not.
(EU GMP-Guide)

Blinding A procedure in which one or more parties to the trial are kept unaware of
the treatment assignment(s). Single-blinding usually refers to the
subject(s) being unaware, and doubleblinding usually refers to the
subject(s), investigator(s), monitor, and, in some cases, data analyst(s)
being unaware of the treatment assignment(s). In relation to an
investigational medicinal product, blinding shall mean the deliberate
disguising of the identity of the product in accordance with the instructions
of the sponsor. Unblinding shall mean the disclosure of the identity of
blinded products.

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Bracketing An experimental design to test only the extremes of, for example, dosage
strength. The design assumes that the extremes will be representative of
all the samples between the extremes.
(WHO GMP).

A science and risk based validation approach such that only

batches on the extremes of certain predetermined and justified design
factors, e.g. strength, batch size and/or pack size, are tested during
process validation. (Annex 15 to the EU GMP Guide)

Bulk Pharmaceuticals Mean materials (both pharmacologically active and inactive) which are
(BPs) intended for use as a component of a drug or biological product. These
include materials manufactured by processes such as: (1) chemical
synthetics; (2) fermentation; (3) recombinant DNA or other biotechnology
methods, (4) isolation/recovery from natural sources, or (5) any
combination of these processes.
(US-API-Guide/Draft 1996)

Bulk Product Any product that has completed all processing stages up to, but not
including, final packaging.
(EU GMP Guide)

Calibration 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.
(WHO GMP)

The set of operations which establish, under specified conditions, the

relationship between values indicated by a measuring instrument or
measuring system, or values represented by a material measure, and the
corresponding known values of a reference standard.
(EU GMP Guide, Glossary)

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.
(EU GMP Guide, Part 2)

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CAPA System for implementing corrective actions and preventice actions

(Corrective Action and resulting from the investigation of complaints, product rejections, non
Preventive Action) conformances, recalls, deviations, audits, regulatory inspections and
findings, and trends from process performance and product quality
monitoring.
(ICH Q10)

Capability Ability of a process to realize of product that will fulfil the requirements of
that product. The concept of process capability can also be defined in
statistical terms.
(ICH Q10 / ISO 9000:2005)

CDER Center for Drug Evaluation and Research. This is a division of the FDA that
deals with the approval of new drugs and the inspection of pharmaceutical
companies.

Cell Bank Cell bank system: A cell bank system is a system whereby successive
batches of a product are manufactured by culture in cells derived from the
same master cell bank. A number of containers from the master cell bank
are used to prepare a working cell bank. The cell bank system is validated
for a passage level or number of population doublings beyond that
achieved during routine production.
Master cell bank: A culture of [fully characterised] cells distributed into
containers in a single operation, processed together in such a manner as
to ensure uniformity and stored in such a manner as to ensure stability. A
master cell bank is usually stored at – 70°C or lower.
Working cell bank: A culture of cells derived from the master cell bank and
intended for use in the preparation of production cell cultures. The
working cell bank is usually stored at – 70°C or
lower.
(EU GMP Guide)

Cell Culture The result from the in-vitro growth of cells isolated from multicellular
organisms.
(EU GMP Guide)

Change Control A formal system by which qualified representatives of appropriate

disciplines review proposed or actual changes that might affect the
validated status of facilities, systems, equipment or processes. The intent
is to determine the need for action that would ensure and document that
the system is maintained in a validated state.
(Annex 15 to the EU GMP Guide)

Change Management A systematic approach to proposing, evaluating, approving, implementing

and reviewing changes. (ICH Q10)

CIP Automatic wet cleaning system of a line and/or equipment in a closed

(Cleaning-In-Place) circuit without dismantling. Efficiency of CIP depends on the 5Ts : time,
temperature, titration, turbulence and technology.
(EHEDG)

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Clean Area An area 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.
(EU GMP Guide)

Clean Room A room designed, maintained, and controlled to prevent particle and
microbiological contamination of the products. Such a room is assigned
and reproducibility meets an appropriate air cleanliness air classification.
(FDA Aseptic Guidance)

Cleaning Validation Cleaning validation is documented evidence that an approved cleaning

procedure will reproducibly remove the previous product or cleaning
agents used in the equipment below the scientifically set maximum
allowable carryover level.
(Annex 15 to the EU GMP Guide)

Clinical Trial Any investigation in human subjects intended to discover or verify the
clinical, pharmacological and/or other pharmacodynamic effects of an
investigational product(s) and/or to identify any adverse reactions to an
investigational product(s), and/or to study absorption, distribution,
metabolism, and excretion of one or more investigational medicinal
product(s) with the object of ascertaining its/their safety and/or efficacy.
(Annex 13 to the EU GMP Guide)

Code of Federal The codification of the general and permanent rules published in the
Regulations (CFR) Federal Register by the executive departments and agencies of the
Federal Government. It is divided into 50 titles that represent broad areas
subject to Federal regulation.

Continued Process Assuring that during routine production the process remains in a state of
Verification, see also control. (FDA Process Validation Guidance).
Ongoing Process
Verification

Commissioning The setting up, adjustment and testing of equipment or a system to

ensure that it meets all the requirements, as specifi ed in the user
requirement specifi cation, and capacities as specifi ed by the designer or
developer. Commissioning is carried out before qualification and
validation.
(WHO GMP)

Comparator Product An investigational or marketed product (i.e. active control), or placebo,

used as a reference in a clinical trial.
(Annex 13 to the EU GMP Guide)

Component Means any ingredient intended for use in the manufacture of a drug
product, including those that may not appear in such a drug product.
(FDA Code of Fed. Regulations)

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Computer System A group of hardware components and associated software designed and
assembled to perform a specific function or group of functions.
(EU GMP Guide, Part 2)

Computerised System A system including the input of data, electronic processing and the output
of information to be used either for reporting or automatic control.
(EU GMP Guide, Glossary)

A process or operation integrated with a computer system.

(EU GMP Guide, Part 2)

Concurrent Validation Validation carried out in exceptional circumstances, justified on the basis
of significant patient benefit, where the validation protocol is executed
concurrently with commercialisation of the validation batches.
(Annex 15 to the EU GMP Guide)

Containment The action of confining a biological agent or other entity within a defined
space.
Primary containment: A system of containment which prevents the escape
of a biological agent into the immediate working environment. It involves
the use of closed containers or safety biological cabinets along with secure
operating procedures.
Secondary containment: A system of containment which prevents the
escape of a biological agent into the external environment or into other
working areas. It involves the use of rooms with specially designed air
handling, the existence of airlocks and/or sterilisers for the exit of
materials and secure operating procedures. In many cases it may add to
the effectiveness of primary containment.
(EU GMP Guide)

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.
(EU GMP Guide, Part 2)

Controlled Area An area constructed and operated in such a manner that some attempt is
made to control the introduction of potential contamination (an air supply
approximating to grade D may be appropriate), and the consequences of
accidental release of living organisms. The level of control exercised
should reflect the nature of the organism employed in the process. At a
minimum, the area should be maintained at a pressure negative to the
immediate external environment and allow for the efficient removal of
small quantities of airborne contaminants.
(EU GMP Guide)

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Corrective Action Action to eliminate the cause of a detected non-conformity or other

undesirable situation. Corrective action is taken to prevent recurrence
whereas preventive action is taken to prevent occurrence.
(ICH Q10 / ISO9000:2005)

CPV (Continuous An alternative approach to process validation in which manufacturing

Process Verification) process performance is continuously monitored and evaluated. (ICH Q8)

CQA (Critical Quality A physical, chemical, biological or microbiological property or characteristic

Attribute) that should be within an appropriate limit, range, or distribution to ensure
the desired product quality. (ICH Q8)

Critical Describes a process step, process condition, test requirement, or other

relevant parameter or item that must be controlled within predetermined
criteria to ensure that the API meets its specification.
(EU GMP Guide, Part 2)

Critical Process Steps Process steps that must be controlled within established operating ranges
to ensure that the API or intermediate will meet specifications for quality
and purity.
(FDA API Guide)

Cross-Contamination Contamination of a starting material, intermediate product, or finished

product with another starting material or product during production.
(WHO GMP)

Contamination of a material or of a product with another material or

product.
(EU GMP Guide)

CS (Control Strategy) A planned set of controls, derived from current product and process
understanding, that assures process performance and product quality. The
controls can include parameters and attributes related to drug substance
and drug product materials and components, facility and equipment
operating conditions, in-process controls, finished product specifications,
and the associated methods and frequency of monitoring and control.
(ICH Q10)

Design Qualification The documented verification that the proposed design of the facilities,
(DQ) systems and equipment is suitable for the intended purpose.
(Annex 15 to the EU GMP Guide)

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Design Space The multidimensional combination and interaction of input variables (e.g.
material attributes) and process parameters that have been demonstrated
to provide assurance of quality. Working within the design space is not
considered as a change. Movement out of te design space is considered to
be a change and would normally initiate a regulatory post approval
change process. Design space is proposed by the applicant and is subject
to regulatory assessment and approval.
(ICH Q8)

Disinfection The reduction, by means of chemical agents and/or physical methods of

the number of micro-organisms in the environment to a level that does
not compromise product safety of suitability.
(EHEDG)

Drug Product Means a finished dosage form, for example, 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
dosage form that does not contain an active ingredient but is intended to
be used as a placebo.
(FDA Code of Fed. Regulations)

EU Directive A legal document which has legal force across Europe, but which requires
implementation in each Member State by means of local
legislation.

EU Guideline Documents which provide guidance regarding certain topics (e.G. GMP). A
Guideline is not intended to place any restraint upon the development of
any new concepts or new technologies which have been validated and
which provide a level of Quality Management at least equivalent to those
set out in the Guideline.
The GMP guide will be regularly revised in order to reflect continual
improvement of best practices in the field of Quality

EU Regulation A legal document which has legal force and direct applicability across
Europe.

EudraCT A European database containing details of all clinical trials in Europe.

Every clinical trial, which is subject to the Clinical Trials Directive, must be
entered onto this database.

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Expiration Date The date (usually placed on the containers/labels of an API) designating
the time during which the API is expected to remain within established
shelf-life specifications if stored under defined conditions and after which
it should not be used.
(FDA API Guide)

The date placed on the container/labels of an API designating the time

during which the API is expected to remain within established shelf life
specifications if stored under defined conditions, and after which it should
not be used.
(EU GMP Guide, Part 2)

Finished Product A product that has undergone all stages of production, including
packaging in its final container and labelling.
(WHO GMP)

A medicinal product which has undergone all stages of production,

including packaging in its final container.
(EU GMP Guide)

HACCP Systematic approach to the identification, evaluation and control of

hazards at identified points within a production process in order to ensure
the delivery of safe products to the patients.
(Internet see also Codex Alimentarius).

Hazard The potential source of a harm.

(ISO/IEC Guide 51)

Impurity Any component present in the intermediate or API that is not the desired
entity.
(EU GMP Guide, Part 2)

Impurity Profile A description of the identified and unidentified impurities present in an

API.
(FDA API Guide and EU GMP Guide, Part 2)

Inactive Ingredient Means any component other than an active ingredient.

(FDA Code of Fed. Regulations)

In-process Control Checks performed during production in order to monitor and if necessary
to adjust the process to ensure that the product conforms to its
specifications. The control of the environment may also be regarded as a
part of in-process control.
(EU GMP Guide)

Checks performed during production in order to monitor and, if

appropriate, to adjust the process and/or to ensure that the intermediate
or API conforms to its specifications.
(EU GMP Guide, Part 2)

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In-process Material Means any material fabricated, compounded, blended, or derived by

(valid for drug/ medicinal chemical reaction that is produced for, and used in, the preparation of the
products) drug product.
(FDA Code of Fed. Regulations)

Inspection The act by a regulatory authority(ies) of conducting an official review of

documents, facilities, records, and any other resources that are deemed
by the authority(ies) to be related to the manufacturing of a medicinal
product, API or other starting material.

Installation The documented verification that the facilities, systems and equipment, as
Qualification (IQ) installed or modified, comply with the approved design and the
manufacturer’s recommendations.
(Annex 15 to the EU GMP Guide)

Intermediate A material produced during steps in the synthesis of an API that must
undergo further molecular change or processing before it becomes an API.
(FDA API Guide)

A material produced during steps of the processing of an API that

undergoes further molecular change or purification before it becomes an
API. Intermediates may or may not be isolated. (Note: this Guide only
addresses those intermediates produced after the point that the company
has defined as the point at which the production of the API begins.)
(EU GMP Guide, Part 2)

Intermediate Product Partly processed material that must undergo further manufacturing steps
before it becomes a bulk product.
(EU GMP Guide)

Investigational A pharmaceutical form of an active substance or placebo being tested or

Medicinal Product used as a reference in a clinical trial, including a product with a marketing
(IMP) authorisation when used or assembled (formulated or packaged) in a way
different from the authorised form, or when used for an unauthorised
indication, or when used to gain further information about the authorised
form.
(Annex 13 to the EU GMP Guide)

Investigational Request for a clinical trial authorisation (CTA) in the EU. An IMPD should
Medicinal Product include summaries of information related to the quality, manufacture and
Dossier control of the IMP, data from non-clinical studies and from its clinical use.
(IMPD) (Detailed guidance for the request for authorisation of a clinical trial on a
medicinal product for human use to the competent authorities, notification
of substantial amendments and declaration of the end of the trial)

Investigational New FDA Application for a clinical trial investigation: the sponsor shall submit
Drug (IND) an IND to FDA if the sponsor intends to conduct a clinical investigation
with an investigational new drug.
(FDA Code of Federal Regulations, 21 CFR 312)

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Investigator A person responsible for the conduct of the clinical trial at a trial site. If a
trial is conducted by a team of individuals at a trial site, the investigator is
the responsible leader of the team and may be called the principal
investigator.
(Annex 13 to the EU GMP Guide)

Key Intermediate Means an intermediate in which at least one essential molecular

characteristic, usually involving the proper stereochemical configuration
required for structure or pharmacological/ physiological activity, is first
introduced into the molecular structure.
(US-API-Guide/Draft 1996)

Knowledge Systematic approach to acquiring, analysing, storing and disseminating

Management information related to products, manufacturing processes and
components.
(ICH Q9, ICH Q10).

Large Volume Sterile solutions intended for parenteral application with a volume of 100
Parenterals ml or more in one container of the finished dosage form. (WHO GMP)

Lifecycle All phases in the life of a product from the initial development through
marketing until the product’s discontinuation. (ICH Q8)

Limit of detection The lowest amount of analyte in a sample which can be detected but not
(analytical chemistry) quantitated as an exact value. The Limit of Detection is mostly a
parameter of limit tests.
(PIC/S)

Limit of detection In the context of the validation of a qualitative microbiological method the
(Microbio) limit of detection is the lowest number of micro-organisms in a sample
that can be detected. A microbiological limit test determines the presence
or absence of micro-organisms. Due to the nature of microbiology, the
limit of detection refers to the number of micro-organisms present in the
original sample before any dilution or incubation steps; it does not refer to
the number of micro-organisms present at the time of testing.

Limit of quantification The lowest amount of analyte in a sample which can be quantitatively
(analytical chemistry) determined with defined precision and accuracy under the stated
experimental conditions.
(PIC/S)

Limit of quantification In the context of the validation of a quantitative microbiological method

(Microbio) the limit of quantification is the lowest number of micro-organisms that
can be accurately counted.

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Lot Means a batch, or a specific identified portion of a batch, having uniform

character and quality within specified limits; or, in the case of a drug
product produced by continuous process, it is a specific identified amount
produced in a unit of time or quantity in a manner that assures its having
uniform character and quality within specified limits.
(FDA Code of Fed. Regulations)

Lot Number Control number, or batch number means any distinctive combination of
letters, numbers, or symbols, or any combination of them, from which the
complete history of the manufacture, processing, packing, holding, and
distribution of a batch or lot of drug product or other material can be
determined.
(FDA Code of Fed. Regulations)

Manufacture All operations of purchase of materials and products, production, quality

control, release, storage, shipment of finished products, and the related
controls.
(EU GMP Guide, Glossary)

All operations of receipt of materials, production, packaging, repackaging,

labelling, relabelling, quality control, release, storage, and distribution of
APIs and related controls.
(EU GMP Guide, Part 2)

Manufacturer A company that carries out at least one step of manufacture. (WHO GMP)

Holder of a Manufacturing Authorisation as described in Article 40 of

Directive 2001/83/EC.
(EU GMP Guide)

Manufacturing Competent Authority permission to manufacture a medicinal product.

Authorisation

Marketing A legal document issued by the competent drug regulatory authority that
Authorisation established the detailed composition and formulation of the product and
(product licence, the pharmacopoeial or other recognised specifications of its ingredients
registration certificate) and of the final product itself, and includes details of packaging, labelling,
and shelf-life.
(WHO GMP)

Master Formula A document or set of documents specifying the starting materials with
their quantities and the packaging materials, together with a description of
the procedures and precautions required to produce a specified quantity
of a finished product as well as the processing instructions, including the
in-process controls.
(WHO GMP)

Master Record A document or set of documents that serve as a basis for the batch
documentation (blank batch record).
(WHO GMP)

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Materials A general term used to denote Raw Materials, Process Aids,

Intermediates, Active Ingredients and Packing Materials.
(EU GMP Guide)

Medicinal Product Any substance or combination of substances presented for treating or

preventing disease in human beings or animals.
Any substance or combination of substances which may be administered
to human beings or animals with a view to making a medical diagnosis or
to restoring, correcting or modifying physiological functions in human
beings or in animals is likewise considered a medicinal product.
(EU GMP Guide)

Methods Validation Means the documented successful evaluation of an analytic method that
provides a high level of assurance that the method will consistently yield
reliable and accurate results, within previously established specifications.
(US-API-Guide/Draft 1996)

Monitoring The act of conducting a planned sequence of observations or

measurements of control parameters to assess whether a defined process
is under control.
(EHEDG)

Near-Missed event An incident that, if not detected in a timely manner, would have affected
the safety of the recipients or donors.
(WHO GMP For Blood Products)

New Chemical Entity Means a chemical that has not been adequately characterised in the
(NCE) literature regarding its physical and chemical properties.
(US-API-Guide/Draft 1996)

New Molecular Entity The designated therapeutic moiety (API) in a dosage form that has not
(NME) been approved for marketing in the United States (also referred to as a
new chemical entity or new drug substance). It may be a complex, simple
ester, or salt of a previously approved API.
(FDA API Guide March 1998)

Ongoing Process also known as continued process verification

Verification (see also Documented evidence that the process remains in a state of control during
Continued Process commercial manufacture.
Verification)

OOS The term OOS Results includes all test results that fall outside the
(Out-Of-Specification) specifications or acceptance criteria established in product files or by the
manufacturer.
(FDA OOS Guidance).

OOL A result of microbiological monitoring exceeded the defined (by guideline

(Out-of-Limit) or internal) limit of detection, e.g. on surfaces - it is a deviation which
(Microbio) requires normally an investigation and CAPA procedure

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Operation(al) The documented verification that the facilities, systems and equipment, as
Qualification (OQ) installed or modified, perform as intended throughout the anticipated
operating ranges.
(Annex 15 to the EU GMP Guide)

Outsourced Activities Activities conducted by a contract acceptor under a written agreement

with a contract giver.
(ICH Q10)

Packaging All operations, including filling and labelling, that a bulk product has to
undergo in order to become a finished product. Sterile filling would not
normally be regarded as part of packaging, the bulk product being the
filled, but not the finally packaged, primary container.
(WHO GMP)

All operations, including filling and labelling, which a bulk product has to
undergo in order to become a finished product.
Note Sterile filling would not normally be regarded as part of packaging,
the bulk product being the filled, but not finally packaged, primary
containers.
(EU GMP Guide)

Packaging Material All material, including printed material, employed in the packaging of a
pharmaceutical product, 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.
(WHO GMP)

Any material employed in the packaging of a medicinal product, 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.
(EU GMP Guide, Glossary)

Any material intended to protect an intermediate or API during storage

and transport.
(EU GMP Guide, Part 2)

PAT (Process A system for designing, analyzing, and controlling manufacturing through
Analytical Technology) timely measurements (i.e., during processing) of critical quality and
performance attributes of raw and in-process materials and processes with
the goal of ensuring final product quality.

Percentage of Means the ratio of the actual yield (at any appropriate phase of
Theoretical Yield manufacture, processing or packaging of a particular drug product) to the
theoretical yield (at the same phase), stated as percentage.
(FDA Code of Fed. Regulations)

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Performance The documented verification that systems and equipment can perform
Qualification (PQ) effectively and reproducibly based on the approved process method and
product specification. (Annex 15 to the EU GMP Guide)

Performance Confirming that the manufacturing process as designed is capable of

Qualification reproducible commercial manufacturing. (FDA Process Validation
Guidance)

Pest Includes birds, bats, rodents and insects whose uncontrolled presence
affects hygiene and cleanliness.
(WHO GMP).

Pharmaceutical Any medicine intended for human use or veterinary product administered
Product 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.
(WHO GMP)

Pivotal Intermediate Means an intermediate that may be prepared by more than one
manufacturing process to provide material of suitable quality for use in the
production of an API.
(US-API-Guide/Draft 1996)

PQS (Pharmaceutical Management system to direct and control a pharmaceutical company with
Quality System) regard to quality. (ICH Q10 based upon ISO 9000:2005)

Precision (quantitative In the context of the validation of a quantitative Rapid Microbiological

method) Method the precision is the degree of agreement among individual test
results when the procedure is applied repeatedly to multiple samplings of
homogeneous suspensions of micro-organisms. The precision is usually
expressed as the variance, standard deviation or coefficient of variation of
a series of measurements.

Pressure Cascade A process whereby air fl ows from one area, which is maintained at a
higher pressure, to another area at a lower pressure.
(WHO GMP).

Preventive Action Action to eliminate the cause of potantial non-conformity or other

undesirable potential situation. Prevention action is taken to prevent
occurrence whereas corrective action is taken to prevent recurrence.
(ICH Q10, ISO9000:2005).

Procedures Description of the operations to be carried out, the precautions to be

taken and measures to be applied directly or indirectly related to the
manufacture of a medicinal product.
(EU GMP Guide)

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Process Aids Materials, excluding solvents, used as an aid in the manufacture of an

intermediate or API that do not themselves participate in a chemical or
biological reaction (e.g. filter aid, activated carbon, etc).
(EU GMP Guide)

Process Robustness Ability of a process to tolerate variability of materials and changes of the
process and equipment without negative impact on quality. (ICH Q8)

Process 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 characteristics.
(FDA API Guide)

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.
(Annex 15 to the EU GMP Guide)

Product Quality Part of Chapter 1 “Quality Management” of the EU-GMP Guide is the
Review (PQR) Product Quality Review (PQR). The aim of this requirement – that has to
be fulfilled for all licensed medicinal products – is to verify
• the consistency and appropriateness of the existing process,
• the adequacy of current specifications for starting material and finished
product
• and to identify product and process improvements.

The PQR covers all aspects of the supply chain: Starting materials,
process, process environment and product.

Product Specification A reference file containing, or referring to files containing, all the
File (PSF) information necessary to draft the detailed written instructions on
processing, packaging, quality control testing, batch release and shipping
of an investigational medicinal product.
The purpose of this file is described its role as the basis for assessment of
the suitability for release and certification of a particular batch. The
information contained in the PSF must be taken into account in the
drawing up of all important work instructions.
(Annex 13 to the EU GMP Guide)

Production All operations involved in the preparation of a pharmaceutical product,

from receipt of materials, through processing and packaging, to
completion of the finished product.
(EU GMP Guide)

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Prospective Validation Establishing documented evidence that a system does what it purports to
do prior to the commercial distribution of a new API or an existing API
made by a new or modified process.
(FDA API Guide)

Validation carried out before routine production of products intended for

sale.
(Annex 15 to the EU GMP Guide)

Purification Procedure A process, such as crystallization, distillation, or chromatography, intended

to improve the purity of an API or intermediate.
(FDA API Guide)

Qualification Action of proving that any equipment works correctly and actually leads to
the expected results. The word validation is sometimes widened to
incorporate the concept of qualification.
(EU GMP Guide, Glossary)

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.
(EU GMP Guide, Part 2)

Qualified Person The person defined in Article 48 of Directive 2001/83/EC and

Article 52 of Directive 2001/82/EC. Each batch of finished product must be
certified by a QP within the EC/EEA before being released for sale or
supply in the EC/EEA or for export.

Quality The degree to which a set of inherent properties of a product, system or

process fulfills requirements. See ICH Q6A definition specifically for
“quality” of pharmaceutical substances and products.
(ICH Q9).

Quality Assurance 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.
(EU GMP Guide, Part 2)

Quality Control Checking or testing that specifications are met.

(EU GMP Guide, Part 2)

Quality Control Unit Means any person or organisational element designated by the firm to be
responsible for the duties relating to quality control.
(FDA Code of Fed. Regulations)

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Quality Manual Document specifying the quality management system of an organisation.

(ICH Q10, ISO9000:2005)

QRM A systematic approach for the assessment, control, communication and

(Quality Risk reivew of risks to the quality of the product across the product lifecycle.
Management) (ICH Q9)

QTTP (Quality Target A prospective summary of the quality characteristics of a drug product
Product Profile) that ideally will be achieved to ensure the desired quality, taking into
account safety and efficacy of the drug product. (ICH Q8)

Quality Unit An organisational unit independent of production which fulfils both Quality
Assurance and Quality Control responsibilities. This can be in the form of
separate QA and QC units or a single individual or group, depending upon
the size and structure of the organisation.
(EU GMP Guide, Part 2)

Quarantine The status of starting or packaging materials, intermediate, bulk or

finished products isolated physically or by other effective means whilst
awaiting a decision on their release or refusal.
(EU GMP Guide, Glossary)

The status of materials isolated physically or by other effective means

pending a decision on their subsequent approval or rejection. (EU GMP
Guide, Part 2)

Randomisation The process of assigning trial subjects to treatment or control groups

using an element of chance to determine the assignments in order to
reduce bias.
(Annex 13 to the EU GMP Guide)

Range (analytical The range of an analytical procedure is the interval between the upper
chemistry) 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.

Range (Microbio) In the context of the validation of a quantitative microbiological method

the range is the interval between the upper and lower levels of micro-
organisms that have been determined with precision, accuracy, and
linearity using the method as written. The range is determined from
studies 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.
(EU GMP Guide, Part 2)

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Reconciliation A comparison, making due allowance for normal variation, between the
amount of product or materials theoretically and actually produced or
used.
(EU GMP Guide)

Recovery The introduction of all or part of previous batches of the required quality
into another batch at a defined stage of manufacture.
(EU GMP Guide)

Reference Standard, A substance that has been shown by an extensive set of analytical tests to
Primary 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.
(EU GMP Guide, Part 2)

Reference Standard, A substance of established quality and purity, as shown by comparison to

Secondary a primary reference standard, used as a reference standard for routine
laboratory analysis.
(EU GMP Guide, Part 2)

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.
(FDA Code of Fed. Regulations)

Reprocessing The reworking of all or part of a batch of product of an unacceptable

quality from a defined stage of production so that its quality may be
rendered acceptable by one or more additional operations.
(EU GMP Guide, Glossary)

Introducing an intermediate or API, including one that does not conform

to standards or specifications, back into the process and repeating a
crystallisation 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. (EU
GMP Guide, Part 2)

Retest Date The date when a material should be re-examined to ensure that it is still
suitable for use.
(EU GMP Guide, Part 2)

Return Sending back to the manufacturer or distributor of a medicinal product

which may or may not present a quality defect.
(EU GMP Guide)

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Returned Product Finished product sent back to the manufacturer.

(WHO GMP)

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., recrystallising with a different solvent).
(EU GMP Guide, Part 2)

Robustness (analytical Measure of an analytical procedure’s capacity to remain unaffected by

chemistry) small, but deliberate, variations in method parameters and provides an
indication of its reliability during normal usage.

Robustness (Microbio) In the context of the validation of a microbiological method the robustness
is a measure of its capacity to remain unaffected by small but deliberate
variations in method parameters, and provides an indication of the
method’s reliability under a variety of normal test conditions, such as
different analysts, instruments, batches of reagents and laboratories.
Robustness can be defined as the intrinsic resistance to the influences
exerted by operational and environmental variables on the results of the
microbiological method.

RTRT (Real Time The ability to evaluate and ensure the quality of in-process and/or final
Release Testing) product based on process data, which typically include a valid combination
of measured material attributes and process controls. (ICH Q8)

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Self-Inspection An internal evaluation of the manufacturer’s compliance with GMP in

relevant aspects of production and quality control.
(WHO GMP).

Specification A document describing in detail the requirements with which the products
or materials used or obtained during manufacture have to conform.
Specifications serve as a basis for quality evaluation. (WHO GMP)

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.
(ICH Q6A October 1999)

A list of tests, references to analytical procedures, and appropriate

acceptance criteria that are numerical limits, ranges, or other criteria for
the test described. It establishes the set of criteria to which a material
should conform to be considered acceptable for its intended use.
“Conformance to specification” means that the material, when tested
according to the listed analytical procedures, will meet the listed
acceptance criteria.
(EU GMP Guide, Part 2)

Specificity In the context of the validation of a Rapid Microbiological Method the

specificity is its ability to detect the required range of micro-organisms
that may be present in the sample under test. For those methods that do
not require growth as an indicator of microbial presence, the specificity
assures that extraneous matter in the test system does not interfere with
the test. Where relevant for the purpose of the test, mixtures of micro-
organisms are used during validation.

Sponsor An individual, company, institution or organisation which takes

responsibility for the initiation, management and/or financing of a clinical
trial.
(Annex 13 to the EU GMP Guide)

Standard Operating An authorised written procedure giving instructions for performing

Procedure (SOP) 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.
(WHO GMP)

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Starting Material Any substance used in the production of a medicinal product, but
excluding packaging materials.
(EU GMP Guide)

Sterility Sterility is the absence of living organisms. The conditions of the sterility
test are given in the European Pharmacopoeia.
(EU GMP Guide)

Strength Means that concentration of the drug substance (for example,

weight/weight, weight/volume, or unit dose/volume basis), and/or the
potency, that is, the therapeutic activity of the drug product as indicated
by appropriate laboratory tests or by adequately developed and controlled
clinical data (expressed, for example, in terms of units by reference to a
standard).
(FDA Code of Fed. Regulations)

System Is used in the sense of a regulated pattern of interacting activities and

techniques which are united to form an organised whole.
(EU GMP Guide)

Theoretical Yield Means the quantity that would be produced at any appropriate phase of
manufacture, processing, or packaging of a particular drug product, based
upon the quantity of components to be used, in the absence of any loss or
error in actual production.
(FDA Code of Fed. Regulations)

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.
(EU GMP Guide, Part 2)

Trend A statistical term referring to the direction or rate of change of a

variable(s).
(ICH Q9).

User Requirement The set of owner, user and engineering requirements necessary and
Specification (URS) sufficient to create a feasible design meeting the intended purpose of the
system.

Validation Action of proving, in accordance with the principles of Good Manufacturing

Practice, that any procedure, process, equipment, material, activity or
system actually leads to the expected results (see also qualification).
(EU GMP Guide, Glossary)

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.
(EU GMP Guide, Part 2)

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Validation Protocol A written plan stating how validation will be conducted and identifying
specific acceptance criteria. For example, the protocol for a typical
manufacturing process identifies processing equipment, critical process
parameters/operating ranges, product characteristics, sampling and test
data to be collected, number of validation runs, and acceptable test
results.
(FDA API Guide)

A written plan stating how validation will be conducted and defining

acceptance criteria. For example, the protocol for a manufacturing process
identifies processing equipment, critical process parameters/operating
ranges, product characteristics, sampling, test data to be collected,
number of validation runs, and acceptable test results.
(EU GMP Guide, Part 2)

VMP Validation master plan is a high-level document which establishes an

Validation Master Plan umbrella validation plan for the entire project, and is used as guidance by
the project team for resource and technical planning (also referred to as
master qualification plan).
(WHO GMP)

Working Standard An API, intermediate or other substance of established quality and purity,
as shown by comparison to a primary reference standard, used as a
reference for routine laboratory analysis.
(FDA API Guide)

Worst Case A condition or set of conditions encompassing upper and lower processing
limits and circumstances, within standard operating procedures, which
pose the greatest chance of product or process failure when compared to
ideal conditions. Such conditions do not necessarily induce product or
process failure.
(Annex 15 to the EU GMP Guide)

Yield, Actual Means the quantity that is actually produced at any appropriate phase of
manufacture, processing, or packaging of a particular drug product.
(FDA Code of Fed. Regulations)

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.
(EU GMP Guide, Part 2)

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.
(EU GMP Guide, Part 2)

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