Abbreviations, acronyms and terminology  – our Glossary contains hundreds of those commonly used within the GMP arena.

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A

Accelerated testing

Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. Data from these studies, in addition to long term stability studies, can be used to assess longer term chemical effects at non-accelerated conditions and to evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping. Results from accelerated testing studies are not always predictive of physical changes. (ICH Q1A(R2))

Acceptance Criteria

Numerical limits, ranges, or other suitable measures for acceptance of test results. (EU GMP Guide Part II)

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). (21CFR210/211)

Numerical limits, ranges, or other suitable measures of test results necessary to determine acceptance of the drug substance, drug products, or materials at stages of their manufacture. (FDA Guidance for Industry, CGMP for Phase 1 Investigational Drugs)

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures. (ICH Q6A)

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet. (ICH Q6B)

Accuracy

The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. (ICH Q2(R1))

Action level

An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation. (FDA Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – CGMP)

Established criteria, e.g. microbial or particulate levels, requiring immediate follow-up and corrective action if exceeded. (PIC/S PI 007-6)

Action limit

An internal (in-house) value used to assess the consistency of the process at less critical steps. (ICH Q6B)

Active Pharmaceutical Ingredient (API) (or Drug Substance)

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 II)

Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (21CFR210/211)

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 Part I)

Air-Handling Unit

The air-handling unit serves to condition the air and provide the required air movement within a facility. (WHO GMP: Main Principles for Pharmaceutical Products)

Alert Level

An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Alert Limits

Established microbial or particulate levels giving early warning of potential drift from normal operating conditions which are not necessarily grounds for definitive corrective action but which require follow-up investigation. (PIC/S PI 007)

Annual Product Review

An evaluation, conducted at least annually, of the quality standards of a drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. (FDA GFI Request for Quality Metrics Draft 07/15)

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 Part II)

Assay

To provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample. (ICH Q2(R1))

Audit, (Quality)

A systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. (21 CFR Part 820)

An examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors. (WHO GMP: Inspections)

Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. (ISO 9000:2015)

Audit criteria

Set of policies procedures or requirements used as a reference against which objective evidence is compared. (ISO 9000:2015)

Audit evidence

Records, statements of fact or other information, which are relevant to the audit criteria and verifiable. (ISO 9000:2015)

Audit findings

Results of the evaluation of the collected audit evidence against audit criteria. (ISO 9000:2015)

Audit programme

Set of one or more audits planned for a soecific time frame and directed towards a specific purpose. (ISO 9000:2015)

Auditor

Person who conducts an audit. (ISO 9000:2015)

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Batch (or Lot)

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 pide 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 Part I)

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 II)

Batch 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. (21CFR210/211)

Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. (21CFR820)

Batch Number (or Lot Number)

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 II)

A distinctive combination of numbers and/or letters which specifically identifies a batch. (EU GMP Guide, Glossary)

Bioburden

The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected. (EU GMP Guide Part II)

Biological Indicator (BI)

A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Biometrics

A method of varifying an inpidual’s identity based on measurement of the inpidual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that inpidual and measurable. (21 CFR Part 11)

Bracketing

The design of a stability schedule such that only samples on the extremes of certain design factors, e.g., strength, package size, are tested at all time points as in a full design. The design assumes that the stability of any intermediate levels is represented by the stability of the extremes tested. Where a range of strengths is to be tested, bracketing is applicable if the strengths are identical or very closely related in composition (e.g., for a tablet range made with different compression weights of a similar basic granulation, or a capsule range made by filling different plug fill weights of the same basic composition into different size capsule shells). Bracketing can be applied to different container sizes or different fills in the same container closure system. (ICH Q1A(R2))

Brokering of active substances

All activities in relation to the sale or purchase of active substances that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person. (GDP for API 2015/C 95/01)

Bulk product

Any product which has completed all processing stages up to, but not including, final packaging. (EU GMP Guide Part I)

Bulk Production Batch

A batch of product, of size described in the application for a marketing authorisation, either ready for assembly into final containers or in inpidual containers ready for assembly to final packs. (A bulk production batch may, for example, consist of a bulk quantity of liquid product, of solid dosage forms such as tablets or capsules, or of filled ampoules. (EU GMP Guide, Annex 16)

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Calibration

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 Part I)

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 II)

Capability

Ability of an object to realize an output that will fulfil the requirements for that output. (ISO 9000:2015)

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 charcterised) cells distributed into containers in a single operation, processed together 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, Glossary)

Change Control

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

Activities for control of the output after formal approval of its product configuration information. (ISO 9000:2015)

Change Management

A systematic approach to proposing, evaluating, approving, implementing and reviewing changes. (ICH Q10)

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.
Note The different degrees of environmental control are defined in the Supplementary Guidelines for the Manufacture of sterile medicinal products. (EU GMP Guide Part I)

Cleaning Validation

Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing medicinal products. (EU GMP Guide, Annex 15)

Cleanroom

A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Climatic zones

The four zones in the world that are distinguished by their characteristic prevalent annual climatic conditions. This is based on the concept described by W. Grimm (Drugs Made in Germany, 28:196-202, 1985 and 29:39-47, 1986).  (ICH Q1A(R2))

Colony Forming Unit (CFU)

A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. One colony forming unit is expressed as 1 CFU. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Combination product

Combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved inpidually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or
(4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another inpidually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect. (21 CFR 3)

Commitment batches

Production batches of a drug substance or drug product for which the stability studies are initiated or completed post approval through a commitment made in the registration application. (ICH Q1A(R2))

Competence

Ability to apply knowledge and skills to achieve intended results. (ISO 9000:2015)

Complaint

Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a (medical) deviceafter it is released for distribution. (21 CFR Part 820)

Expression of dissatisfaction made to an organization, related to its product or service, or the complaints-handling process itself, where a respones or resolution is explicitly or implicitly expected. (ISO 9000:2015)

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 II)

Computerized 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 Part I)

A process or operation integrated with a computer system. (EU GMP Guide Part II)

Component

Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. (21CFR210/211)

Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. (21CFR820)

Concession

Premission to use or release a product or service that does not conform to specified requirements. (ISO 9000:2015)

Configuration

Interrelated functional and physical characteristics of a product or service defined in product. (ISO 9000:2015)

Configuration management

Coordinated activities to direct and control configuration. (ISO 9000:2015)

Conformity

Fulfilment of a requirement. (ISO 9000:2015)

Consignee

The person to whom the shipment is to be delivered whether by land, sea or air. (GDP for API 2015/C 95/01)

Container closure system

The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. (ICH Q1A(R2))

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 II)

Continual Improvement

Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Recurring activity to increase the ability to fulfil requirements. (ICH Q10)

Recurring activity to enhance performance. (ISO 9000:2015)

Continued Process Verification

Assuring thet during routine production the process remains in a state of control. (FDA Guidance for Industry: Process Validation: General Principles and Practices)

Continuous Process Verification

An alternative approach to process validation in which manufacturing process performance is continuosly monitored and evaluated. (ICH Q8(R2))

Contract Manufacturer

A manufacturer performing some aspect of manufacturing on behalf of the original manufacturer. (EU GMP Guide Part II)

Control Number

Any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished (medical) devices can be determined. (21 CFR Part 820)

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)

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 Part I)

Correction

Action for eliminating an identified fault.

Repair, rework, or adjustment relating to the disposition of an existing discrepancy (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Action to eliminate a detected nonconformity. (ISO 9000:2015)

Corrective Action

Action taken to eliminate the cause of a defected fault or another undesired situation.

Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrance (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Action to eliminate the cause of a detected non-conformity or other undesirable situation. NOTE: Corrective Action is taken to prevent recurrance whereas preventive action is taken to prevent occurence. (ICH Q10)

Action taken to eliminate the cause of a nonconformity and to prevent recurrence. (ISO 9000:2015)

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 II)

Critical Process Parameter (CPP)

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.  (EMA Guideline on manufacture of the finished dosage form, Draft 02/15)

Critical Quality Attribute (CQA)

Aphysical, 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(R2))

Cross-Contamination

Contamination of a material or of a product with another material or product. (EU GMP Guide Part I)

Contamination of a material or product with another material or product. (EU GMP Guide Part II)

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D Value

The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Data integrity

Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends.
System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data’s life cycle. (FDA, Data Integrity and Compliance With Drug CGMP – Questions and Answers – Guidance for Industry, Dec 2018)

The extent to which all data are complete, consistent and accurate throughout the data lifecycle. The data should comply with ALCOA+ principles (PIC-S, PI041-1, Draft 3)

Decision Maker(s)

Person(s) with the competence and authority to make appropriate and timely quality risk management decisions. (ICH Q9)

Decontamination

A process that eliminates viable bioburden via use of sporicidal chemical agents. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Defect

Nonconformity related to an intended or specified use. (ISO 9000:2015)

Design History File (DHF)

Compilation of records which describes the design history of finished (medical) device. (21 CFR Part 820)

Design Input

The physical and performance requirements of a (medical) device that are used as a basis for device design. (21 CFR Part 820)

Design of Experiments

A structured, organized method for determining the relationship between factors affecting a process and the output of that process. (ICH Q8(R2))

Design Output

The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the (medical) device, its packaging and labeling, and the device master record. (21 CFR Part 820)

Design Qualification (DQ)

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

Design Review

A documented, comprehensive, systematic examination of a deisgn to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. (21 CFR Part 820)

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 the 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(R2))

Design Validation

Means establishing bu objective evidence that device specifications conform with user needs and intended use(s). (21 CFR 820.3 (z)(2)

Detectability

The ability to discover or determine the existence, presence, or fact of a hazard. (ICH Q9)

Detection Limit

The detection limit of an inpidual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. (ICH Q2(R1))

Deviation

Departure from an approved instruction or established standard (EU GMP Guide Part II)

Device History Record (DHR)

A compilation of records containing the production history of a finished (medical) device. (21 CFR Part 820)

Device Master Record (DMR)

A compilation of records containing the procedures and specification for a finished (medical) device. (21 CFR Part 820)

Digital Signature

An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR Part 11)

Disinfection

Process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Distribution of active substances

All activities consisting of procuring, importing, holding, supplying or exporting of active substances, apart from brokering. (GDP for API 2015/C 95/01)

Dosage form

A pharmaceutical product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally, but not necessarily, in association with excipients. (ICH Q1A(R2))

Drug (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 Part I)

The dosage form in the final immediate packaging intended for marketing. (ICH Q1A(R2)) (EU GMP Guide Part II)

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. (21CFR210/211)

Drug Substance

See Active Pharmaceutical Ingredient (EU GMP Guide Part II and 21CFR210/211)

The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form. (ICH Q1A(R2))

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Efficiency

Relationship between the result achieved and the resources used. (ISO 9000:2015)

Effectiveness

Extent to which planned activities are realized and planned results used. (ISO 9000:2015)

Electronic Record

Any combination of text, graphics, data, audio, pictoral, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. (21 CFR Part 11)

Electronic Signature

An electronic measure that can be substituted for a handwritten signature or initials for the purpose of signifying approval, authorisation of verification of specific data entries. See also definition for ‘Advanced Electronic Signature’, above. (PIC/S PI 011)

Endotoxin

A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Establish

Means define, document (in writing or electronically), and implement. (21 CFR Part 820)

Establishment

A place of business under one management at one general physical location. The term includes, among others, independent laboratories that engage in control activities for a registered drug establishment (e.g., contract laboratories). (FDA GFI Request for Quality Metrics Draft 07/15)

Excipient

Anything other than the drug substance in the dosage form. (ICH Q1A(R2))

Expiry Date (or Expiration Date)

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 II)

Export procedure

Export procedure: allow Community goods to leave the customs territory of the Union. For the purpose of these guidelines, the supply of medicines from EU Member State to a contracting State of the European Economic Area is not considered as export. (GDP 2013/C 343/01)

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Falsified active substance

Any active substance with false representation of:

a) its identity, including its packaging and labeling, its name or its components as regards any of the ingredients and the strength of those ingredients;

b) its source, including its manufacturer, its country of manufacture, its country of origin; or

c) its history, including the records and documents relating to the distribution channels used.

(GDP for API 2015/C 95/01)

Falsified medicinal product

Any medicinal product with a false representation of:

a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;

b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

c) its history, including the records and documents relating to the distribution channels ised.

(GDP 2013/C 343/01)

Fiber

Fiber means any particulate contaminant with a length at least three times greater than its width. (21CFR210/211)

Finished Device

Means any (medical) device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. (21 CFR Part 820)

Finished product

A medicinal product which has undergone all stages of production, including packaging in its final container. (EU GMP Guide Part I)

Free zones and free warehouses

Free zones and free warehouses are parts of the customs territory of the Community or premises situated in that territory and separated from the rest if it in which:

(a) Community goods are considered, for the purpose of import duties and commercial policy import measures, as not being on Community customs territory, provided they are not released for free circulation or placed under another customs procedure or used or consumed under conditions other than those provided for in customs regulations;

(b) Community goods for which such provision is made under Community legislation governing specfic fields qualify, by virtue of being placed in a free zone or free warehouse, for measures normally attaching to the export of goods.

(GDP 2013/C 343/01)

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Gang-printed labeling

Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed.  (21CFR210/211)

Good Distribution Practice (GDP)

GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public. (GDP 2013/C 343/01)

Good Engineering Practice

Those established engineering methods and standards that are applied throughout the life-cycle to deliver appropriate and cost-effective solutions. (ISPE Baseline Guide)

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Harm

Damage to health, including the damage that can occur from loss of product quality or availability. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations; ICH Q9)

Physical injury or damage to the health of people, or damage to property or the environment. (ISO/IEC Guide 51:1999)

Hazard

The potential source of harm. (ICH Q9)

HEPA Filter

High efficiency particulate air filter with minimum 0.3 µm particle retaining efficiency of 99.97 percent. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Holding

Storing active substances. (GDP for API 2015/C 95/01)

Storing medicinal products. (GDP 2013/C 343/01)

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Impurity

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

Impurity Profile

A description of the identified and unidentified impurities present in an API. (EU GMP Guide Part II)

Inactive ingredient

Inactive ingredient means any component other than an ”active ingredient.”

In-Process Control (or Process Control)

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

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 II)

Intermediate

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

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 II)

Intermediate Precision

Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. (ICH Q2(R1))

In-process material

In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. (21CFR210/211)

Invalidated OOS

Any out-of-specification result that was invalidated. Note: Invalidation of a discrete test result may be done only upon the observation and documentation of a test event that can reasonably be determined to have caused the OOS result.
For the purpose of this guidance, this includes: (1) finished product and stability test results only and, (2) all finished product and stability test results that initially appear as OOS, even if invalidated by a subsequent laboratory investigation. (FDA GFI Request for Quality Metrics Draft 07/15)

K Up ↑

Knowledge Management

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

L Up ↑

Label

A display of written, printed, or graphic matter upon the immediate container. (U.S. Food, Drug and Cosmetic Act, Rev. 11/98)

Labeling

All labels and other written, printed, or graphic matters upon any article or any of its containers or wrappers, or accompanying such article. (U.S. Food, Drug and Cosmetic Act, Rev. 11/98)

Limit of Detection (LOD)

The lowest amount of analyte in a sample which can be detected but not quantiated as an exact value. The Limit of Detection is mostly a parameter of limit tests. (PIC/S PI 006)

Limit of Quantification (LOQ)

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 PI 006)

Linearity

The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample. (ICH Q2(R1))

Lot

See Batch (EU GMP Guide Part II)

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. (21CFR210/211)

Lot Number

See Batch Number (EU GMP Guide Part II)

M Up ↑

Management

Coordinated activities to direct and control an organization. (ISO 9000:2015)

Manufacture

All operations of purchase of materials and products, production, quality control, release, storage, distribution of medicinal products and the related controls. (EU GMP Guide Part I)

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 II)

Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products. (21CFR210/211)

Manufacturer

Holder of a Manufacturing Authorisation as described in Article 40 of Directive 2001/83/EC. (EU GMP Guide, Glossary)

Any person who designs, manufactures, fabricates, assembles, or processes a finished (medical) device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. (21 CFR Part 820)

A person who takes responsibility for and is involved in any aspect of the manufacture of a phase 1 investigational drug. (FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs)

Manufacturing Material

Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished (medical) device as a residue or impurity not by design or intent of the manufacturer. (21 CFR Part 820)

Material

A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, APIs and packaging and labelling materials. (EU GMP Guide Part II)

Medicinal (Drug) 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 Part I)

The dosage form in the final immediate packaging intended for marketing. (Reference Q1A). (EU GMP Guide Part II)

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. (21CFR210/211)

Monitoring

Determining the status of a system, a process, a product, a service or an activity. (ISO 9000:2015)

Mother Liquor

The residual liquid which remains after the crystallization or isolation processes. A mother liquor may contain unreacted materials, intermediates, levels of the API and/or impurities. It may be used for further processing. (EU GMP Guide Part II)

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Non-Conformity (nonconformity)

The nonfulfillment of a specified requirement. (21 CFR Part 820)

A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Non-fulfilment of a requirement. (ISO 9000:2015)

Non-fiber-releasing filter

Means any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. (21CFR210/211)

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Objective Evidence

Data supporting the existence or verity of something. (ISO 9000:2015)

P Up ↑

Packaging

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 Part I)

Packaging Material

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 Part I)

Any material intended to protect an intermediate or API during storage and transport. (EU GMP Guide Part II)

Parametric Release

A system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric Release. (EU GMP Guide, Annex 17)

Preventive Action

Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Action to eliminate the cause of a potential non-conformity or other undesirable potential situation. Note: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. (ISO 9000:2015) (ICH Q10)

Procedure(s)

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 Part I)

A documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of an intermediate or API. (EU GMP Guide Part II)

Specified way to carry out an activity or a process. (ISO 9000:2015)

Process

Set of interrelated or interacting activities that use inputs to deliver an intended result. (ISO 9000:2015)

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 Part II)

Process Capability Index (CpK)

A process capability index CpK represents the true measure of process capability

CpK = (X – LSL)/3s

or = (USL – X)/3s

where

LSL = Lower specification limit

USL = Upper specification limit

X = Mean

s = Standard deviation (PIC/S PI 006)

Process Capability

Ability of a process to realise a product that will fulfil the requirements of that product. The concept of process capability can also be defined in statistical terms. (ICH Q10)

A statistical estimate of the outcome of a characteristic from a process that has been demonstrated to be in a state of statistical control. (FDA GFI Request for Quality Metrics Draft 07/15)

Process Capability Index

Ability of a process to realise a product that will fulfil the requirements of that product. The concept of process capability can also be defined in statistical terms. (ICH Q10)

An index describing process capability in relation to a specified tolerance. (FDA GFI Request for Quality Metrics Draft 07/15)

Process Control

See In-Process Control (EU GMP Guide Part II)

Process Performance

A statistical measure of the outcome of a characteristic from a process that may not have been demonstrated to be in a state of statistical control. (FDA GFI Request for Quality Metrics Draft 07/15)

Process Performance Index

An index describing process performance in relation to specified tolerance. (FDA GFI Request for Quality Metrics Draft 07/15)

Process Performance Qualification

The second element of the Process Qualification. It includes a combination of the actual facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful PPQ will confirm the process design and demonstrate that the commercial manufacturing process performs as expected. Batches prepared are also called Conformance batches of PPQ batches. ( FDA Guidance for Industry: Process Validation: General Principles and Practices, 2011)

Process Qualification

Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (FDA Guidance for Industry: Process Validation: General Principles and Practices)

Process Validation

The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. (EU GMP Guide, Annex 15)

The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products. (FDA Guidance for Industry: Process Validation: General Principles and Practices)

Means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. (21 CFR 820.3 (z)(1))

Procuring

Obtaining, acquiring, purchasing or buying active substances from manufacturers, importers or other distributors. (GDP for API 2015/C 95/01)

Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors. (GDP 2013/C 343/01)

Product

Components, manufacturing materials, in- process devices, finished devices, and returned devices. (21 CFR Part 820)

Output of an organization that can be produced without any transaction taking place between the organization and the customer. (ISO 9000:2015)

Product Lifecycle

All phases in the life of the product from the initial development through marketing until the product’s discontinuation. (ICH Q9)

Product Quality Complaint

A complaint involving any possible, including actual, failure of a drug product to meet any of its specifications designed to ensure that any drug products conform to appropriate standards of identity strength, quality, and purity. (FDA GFI Request for Quality Metrics Draft 07/15)

Product Quality Review (PQR)

Regular periodic or rolling quality reviews of all licensed medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product to highlight any trends and to identify product and process improvements. Such reviews should normally be conducted and documented annually, taking into account previous reviews. (EU GMP Guide, Part I, chapter 1.4)

Regular quality reviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should normally be conducted and documented annually. (EU GMP Guide, Part II, chapter 2.60)

Production

All operations involved in the preparation of a medicinal product, from receipt of materials, through processing and packaging, to its completion as a finished product. (EU GMP Guide Part I)

All operations involved in the preparation of an API from receipt of materials through processing and packaging of the API. (EU GMP Guide Part II)

Prospective Validation

Validation carried out before routine production of products intended for sale. (EU GMP Guide, Annex 15)

Proven Acceptable Range (PAR)

A characterised range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria. (ICH Q8(R2))

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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 Part I)

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 inpidual qualification steps alone do not constitute process validation. (EU GMP Guide Part II)

Qualified Person (Q.P.)

The person defined in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC. (EU GMP Guide, Annex 16)

Quality

The totality of features and characteristics that bear on the ability of a (medical) device to satisfy fitness-for-use, including safety and performance. (21 CFR Part 820)

A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

The suitability of either a drug substance or drug product for its intended use. this term includes such attributes as the identity, strenght, and purity. (ICH Q8(R2))

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 drug substance and drug (medicinal) products.) (ICH Q9, ICH Q10)

Degree to which a set of inherent characteristics of an object fulfils requirements. (ISO 9000:2015)

Quality Assurance (QA)

The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained. (EU GMP Guide Part II)

Part of quality management focused on providing confidence that quality requirements will be fulfilled. (ISO 9000:2015)

Quality Audit

A systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. (21 CFR Part 820)

An examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose. Such audits may also be extended to suppliers and contractors. (WHO GMP: Inspections)

Quality by Design (QbD)

A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (ICH Q8(R2))

Quality Control (QC)

Checking or testing that specifications are met. (EU GMP Guide Part II)

Part of quality management focused on fulfilling quality requirements. (ISO 9000:2015)

The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Quality Unit(s), Quality Control Unit

An organizational unit independent of production which fulfills both Quality Assurance and Quality Control responsibilities. This can be in the form of separate QA and QC units or a single inpidual or group, depending upon the size and structure of the organization. (EU GMP Guide Part II)

Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control. (21CFR210/211)

Quality Management

Accountability for the successful implementation of the quality system. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Management with regard to quality. (ISO 9000:2015)

Quality Manual

Document specifying the quality management system of an organisation.  (ICH Q10)

Specification for the quality management system of an organization.  (ISO 9000:2015)

Quality Objectives

Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

A means to translate the quality policy and strategies into measurable activities. (ICH Q10)

Quality Plan

The documented result of quality planning that is disseminated to all relevant levels of the organization. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Quality Planning

A management activity that sets quality abjectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to achieve the quality objectives. (ISO 9000:2015) (ICH Q10)

Quality Policy

The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. (21 CFR Part 820)

A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Overall intentions and direction of an organisation related to quality as formally expressed by senior management. (ICH Q10)

Policy related to quality. (ISO 9000:2015)

Quality Risk Management

A systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. (ICH Q9, ICH Q10)

Quality System

The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. (21 CFR Part 820)

Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

The sum of all aspects of a system that implements quality policy and ensures that quallity objectives are met. (ICH Q9)

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 Part I)

The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection. (EU GMP Guide Part II)

R Up ↑

Range

The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. (ICH Q2(R1))

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 II)

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(R2))

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 Part I)

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 Part I)

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 II)

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 II)

Regulatory requirement

Obligatory requirement specified by an authority mandated by a legislative body. (ISO 9000:2015)

Remanufacturer

Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished (medical) device that significantly changes the finished device’s performance or safety specifications, or intended use. (21 CFR Part 820)

Repeatability

Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision. (ICH Q2(R1)

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. (21CFR210/211)

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 Part I)

Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an in-process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing. (EU GMP Guide Part II)

Reproducibility

Reproducibility expresses the precision between laboratories (collaborateive studies, usually applied to standardization of methodology). (ICH Q2(R1))

Requirements

The explicit or implicit needs or expectations of the patients or their surrogates (e.g., health care professionals, regulators and legislators). In this document, “requirements” refers not only to statutory, legislative, or regulatory requirements, but also to such needs and expectations. (ICH Q9)

Retest Date

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

Retrospective Validation

Validation of a process for a product which has been marketed based upon accumulated manufacturing, testing and control batch data. (EU GMP Guide, Annex 15; PIC/S PI 006)

Return

Sending back to the manufacturer or distributor of a medicinal product which may or may not present a quality defect. (EU GMP Guide Part I)

Residual Risk

Risk remaining after protective measures have been taken. (ISO/IEC Guide 51:1999)

Re-Validation

A repeat of the process validation to provide an assurance that changes in the process/equipment introduced in accordance with change control procedures do not adversely affect process characteristics and product quality. (EU GMP Guide, Annex 15)

Rework

Action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (21 CFR Part 820)

Action on a nonconforming product or service to make it conform to the requirements. (ISO 9000:2015)

Reworking

Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). (EU GMP Guide Part II)

Risk

The combination of the probability of occurence of harm and the severity of that harm. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations; ICH Q9)

Risk Acceptance

The decision to accept risk. (ICH Q9)

Risk Analysis

Method to assess and characterise the critical parameters in the functionality of an equipment or process. (EU GMP Guide, Annex 15)

The estimation of the risk associated with the identified hazards. (ICH Q9)

Systematic use of available information to identify hazards and to estimate the risk. (ISO/IEC Guide 51:1999)

Risk Assessment

Overall process comprising a risk analysis and a risk evaluation. (ISO/IEC Guide 51:1999)

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consist of the identification of hazards and the analysis and the evaluation of risks associated with exposure to those hazards. (ICH Q9)

Risk Communication

The sharing of information about risk and risk management between the decision maker and other stakeholders. (ICH Q9)

Risk Control

Process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels. (ISO 14971:2000)

Actions implementing risk management decisions. (ICH Q9)

Risk Evaluation

Judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context based on the current values of society. (ISO/IEC Guide 51:1999)

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk. (ICH Q9)

Risk Identification

The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description. (ICH Q9)

Risk Management

Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk. (ISO 14971:2000)

Risk Reduction

Actions taken to lessen the probability of occurence of harm and the severity of that harm. (ICH Q9)

Risk Review

Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk. (ICH Q9)

Robustness

The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. (ICH Q2(R1))

S Up ↑

Senior Management

Person(s) who direct and control a company or site at the highest levels with the authority and responsibility to mobilise resources within the company or site. (ICH Q10)

Top management officials in a firm who have the authority and responsibility to mobilize resources. (FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations)

Severity

A measure of the possible consequences of a hazard. (ICH Q9)

Signature (signed)

See definition for signed (EU GMP Guide Part II)

Signed (signature)

The record of the inpidual who performed a particular action or review. This record can be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature. (EU GMP Guide Part II)

Solvent

An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API. (EU GMP Guide Part II)

Specification

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 II)

Means any requirement with which a product, process, service, or other activity must conform. (21 CFR 820.3(y))

Document stating requirements. (ISO 9000:2015)

Specificity

Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an inpidual analytical procedure may be compensated by other supporting analytical procedure(s). (ICH Q2(R1))

Stakeholder

Any inpidual, group or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, healthcare professional, regulatory authority, and industry. (ICH Q9)

Starting material

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

Statutory requirement

Obligatory requirement specified by a legislative body. (ISO 9000:2015)

Sterile Product

For purpose of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

Sterility

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

Strength

Strength means:
(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or
(ii)  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). (21CFR210/211)

Supplier

Organization that provides a product or a service. (ISO 9000:2015)

Supplying

All activities of providing, selling, donating active substances to distributors, pharmacists, or manufacturers of medicinal products. (GDP for API 2015/C 95/01)

All activities of providing, selling, donating medicinal products to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the public. (GDP 2013/C 343/01)

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 Part I)

Set of interrelated or interacting elements. (ISO 9000:2015)

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Terminal Sterilization

The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of greater than one in a million). (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

(stérilisation en phase terminale) Sterilizing a drug in its final closed container. (Canada GMP Guidelines 2009)

Top Management

Person or group of people who directs and controls an organization at the highest level (ISO 9000:2015)

Traceability

Ability to trace the history, application or location of an object. (ISO 9000:2015)

Transport (transportation)

Moving active substances between two locations without storing them for unjustified periods of time. (GDP for API 2015/C 95/01)

Moving medicinal products between two locations without storing them for unjustified periods of time. (GDP 2013/C 343/01)

Trend

A statistical term referring to the direction or rate of change of variable(s). (ICH Q9)

U Up ↑

Unidirectional Flow

An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice)

V Up ↑

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 II)

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (ISO 9000:2015)

Validation Protocol

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 II)

Verification

Means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. (21 CFR 820.3(aa))

W Up ↑

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. (EU GMP Guide, Annex 15; PIC/S PI 006)

A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, that pose the greatest chance of process or product failure (when compared to ideal conditions). Such conditions do not necessarily induce product or process failure. (FDA Guidance for Industry Sterile Drug PRoducts Produced by Aseptic Processing – Current Good Manufacturing Practice)

Y Up ↑

Yield, actual

Means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. (21CFR210/211)

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 II)

Yield, percentage of theoretical

Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. (21CFR210/211)

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 II)

Means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing 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. (21CFR210/211)