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Glossary of Terms

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.

A list of GMP-relevant abbreviations and their explanations is also available here.

A - from Acceptance Criteria to Audit

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 (qualitative method)	In the context of the validation of a Rapid Microbiological Method accuracy 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 method)	In the context of the validation of a quantitative Rapid Microbiological 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 Ingredient (API)	A substance or compound that is intended to be used in the manufacture 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)
Advanced Technology Medicinal Product (ATMP)	Any one of the following: A gene therapy medicinal product; a somatic cell therapy medicinal product; a tissue-engineered product.
Adverse Drug Reaction (ADR)	All harmful and unintended responses to a medicinal product related to 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)
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).

B - from Batch to Bulk Product

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)
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 Pharmaceutical Ingredient	A material originating from a biological manufacturing process intended to furnish pharmacological activity or other direct effect in the cure, 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.
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 (BPs)	Mean materials (both pharmacologically active and inactive) which are 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)

C - from Calibration to CS (Control Strategy)

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)
CAPA (Corrective Action and Preventive Action)	System for implementing corrective actions and preventice actions resulting from the investigation of complaints, product rejections, non 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 (Cleaning-In-Place)	Automatic wet cleaning system of a line and/or equipment in a closed circuit without dismantling. Efficiency of CIP depends on the 5Ts : time, temperature, titration, turbulence and technology. (EHEDG)
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 Regulations (CFR)	The codification of the general and permanent rules published in the 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 Verification, see also Ongoing Process Verification	Assuring that during routine production the process remains in a state of control. (FDA Process Validation Guidance).
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)
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)
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 Process Verification)	An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated. (ICH Q8)
CQA (Critical Quality Attribute)	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. (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)

D - from Design Qualification (DQ) to Drug Product

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

E - from EU Directive to Expiration Date

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.
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)

F and H - fron Finished Produrct to Hazard

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)

I - from Impurity to Investigator

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)
In-process Material (valid for drug/ medicinal products)	Means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the 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 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. (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 Medicinal Product (IMP)	A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a product with a marketing 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 Medicinal Product Dossier (IMPD)	Request for a clinical trial authorisation (CTA) in the EU. An IMPD should include summaries of information related to the quality, manufacture and control of the IMP, data from non-clinical studies and from its clinical use. (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 Drug (IND)	FDA Application for a clinical trial investigation: the sponsor shall submit 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)
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)

K - from Key Intermediate to Knowledge Management

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 Management	Systematic approach to acquiring, analysing, storing and disseminating information related to products, manufacturing processes and components. (ICH Q9, ICH Q10).

L - from Large Volume Parenterals to Lot Number

Large Volume Parenterals	Sterile solutions intended for parenteral application with a volume of 100 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 (analytical chemistry)	The lowest amount of analyte in a sample which can be detected but not quantitated as an exact value. The Limit of Detection is mostly a parameter of limit tests. (PIC/S)
Limit of detection (Microbio)	In the context of the validation of a qualitative microbiological method the 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 (analytical chemistry)	The lowest amount of analyte in a sample which can be quantitatively determined with defined precision and accuracy under the stated experimental conditions. (PIC/S)
Limit of quantification (Microbio)	In the context of the validation of a quantitative microbiological method the limit of quantification is the lowest number of micro-organisms that can be accurately counted.
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)

M - from Manufacture to Monitoring

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 Authorisation	Competent Authority permission to manufacture a medicinal product.
Marketing Authorisation (product licence, registration certificate)	A legal document issued by the competent drug regulatory authority that established the detailed composition and formulation of the product and the pharmacopoeial or other recognised specifications of its ingredients 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)
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)

N and O - from Near-Missed event to Outsourced Activities

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 (NCE)	Means a chemical that has not been adequately characterised in the literature regarding its physical and chemical properties. (US-API-Guide/Draft 1996)
New Molecular Entity (NME)	The designated therapeutic moiety (API) in a dosage form that has not 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 Verification (see also Continued Process Verification)	also known as continued process verification Documented evidence that the process remains in a state of control during commercial manufacture.
OOS (Out-Of-Specification)	The term OOS Results includes all test results that fall outside the specifications or acceptance criteria established in product files or by the manufacturer. (FDA OOS Guidance).
OOL (Out-of-Limit) (Microbio)	A result of microbiological monitoring exceeded the defined (by guideline or internal) limit of detection, e.g. on surfaces - it is a deviation which requires normally an investigation and CAPA procedure.
New Molecular Entity (NME)	The designated therapeutic moiety (API) in a dosage form that has not 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 Verification (see also Continued Process Verification)	also known as continued process verification Documented evidence that the process remains in a state of control during commercial manufacture.
OOS (Out-Of-Specification)	The term OOS Results includes all test results that fall outside the specifications or acceptance criteria established in product files or by the manufacturer. (FDA OOS Guidance).
OOL (Out-of-Limit) (Microbio)	A result of microbiological monitoring exceeded the defined (by guideline or internal) limit of detection, e.g. on surfaces - it is a deviation which requires normally an investigation and CAPA procedure
Operation(al) Qualification (OQ)	The documented verification that the facilities, systems and equipment, as 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)

P - from Packaging to Purification Procedure

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 Analytical Technology)	A system for designing, analyzing, and controlling manufacturing through 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 Theoretical Yield	Means the ratio of the actual yield (at any appropriate phase of 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)
Performance Qualification (PQ)	The documented verification that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification. (Annex 15 to the EU GMP Guide) Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (FDA Process Validation Guidance)
Pest	Includes birds, bats, rodents and insects whose uncontrolled presence affects hygiene and cleanliness. (WHO GMP).
Pharmaceutical Product	Any medicine intended for human use or veterinary product administered to food-producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state. (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 Quality System)	Management system to direct and control a pharmaceutical company with regard to quality. (ICH Q10 based upon ISO 9000:2005)
Precision (quantitative method)	In the context of the validation of a quantitative Rapid Microbiological 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)
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 Review (PQR)	Part of Chapter 1 “Quality Management” of the EU-GMP Guide is the 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 File (PSF)	A reference file containing, or referring to files containing, all the 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)
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)

Q - from Qualification to Quarantine

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)
Quality Manual	Document specifying the quality management system of an organisation. (ICH Q10, ISO9000:2005)
QRM (Quality Risk Management)	A systematic approach for the assessment, control, communication and reivew of risks to the quality of the product across the product lifecycle. (ICH Q9)
QTTP (Quality Target Product Profile)	A prospective summary of the quality characteristics of a drug product 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)

R- from Randomisation to RTRT (Real Time Release Testing)

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 chemistry)	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.
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)
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, 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. (EU GMP Guide, Part 2)
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. (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)
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 chemistry)	Measure of an analytical procedure’s capacity to remain unaffected by 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 Release Testing)	The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls. (ICH Q8)

S - from Self-Inspection to System

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 Procedure (SOP)	An authorised 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. (WHO GMP)
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)

T and U - from Theoretical Yield to VMP, Validation Master Plan

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 Specification (URS)	The set of owner, user and engineering requirements necessary and 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)
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	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 (also referred to as master qualification plan). (WHO GMP)

W and Y - from Working Standard to Yield, Theoretical

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)