GMP Glossary & Definitions

Accelerated Stability Studies:

The accelerated stability studies are designed to increase the rate of chemical degradation or physical change of a Drug Substance (DS) / Active Pharmaceutical Ingredient (API) or Drug Product (DP) using exaggerated storage conditions. The purpose of the study is to monitor any degradation reactions which than will help to predict the shelf life of a Drug Substance (API) or Drug Product (DP) under the defined (ICH) storage conditions.

 

Acceptance Criteria:

The acceptance criteria are pre-defined and agreed standards, limits or ranges between different parties such as Quality Assurance and Quality Control or Manufacturing and Quality Assurance or suppliers

or

The 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 of raw material, intermediate, packaging material, or active pharmaceutical ingredient. This term can also be applied to validation.

ACT:

Means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to these regulations.

Action Level:

The action level is a pre-defined and between different parties agreed written level. Once these levels are exceeded, actions must be undertaken. A complete investigation must be carried out and documented accordingly.

Active ingredient:

Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to effect the structure 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.

Active Pharmaceutical Ingredient (API):

An API also called Drug Substance (DS) is any physiologically active substance that is intended for use in a Drug Product. An API is also a substance when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished Dosage Form of the Drug.

or

Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body of humans or other animals. APIs include substances manufactured by processes such as chemical synthesis; fermentation; recombinant DNA or other biotechnology methods; isolation/recovery from natural sources; or any combination of these processes.

Actual Yield:

The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate.

ADE - Adverse Drug Event

Any adverse event associated with the use of a drug in humans, whether or not considered drug related.

Adulterated Product:

Adulterated Product is a Product or Medical Devices when it contains any filthy, putrid or decomposed Substance. This also applies for a Product or Medical Devices when it was prepared under unsanitary conditions or was not made in accordance with the GMPs. This could be also a Product or Medical Devices which contains an unsafe colour additive, or does not meet the requirements of an official compendium or Product registration.

Analytical methods validation:

The process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications.

US Health Agency:

The United States Food and Drug Administration (FDA).

Airlock:

An airlock is called a room or space with two or more doors that is interposed between two or more rooms. This is usually build in between different class of cleanliness, for the purpose of controlling the air flow and pressure differential between those rooms. An airlock is designed for personnel or goods.

Alert Level:

The alert level is a pre-defined and between different parties agreed written level. This level should be used to predict an action level. Once these levels are exceeded an investigation may not be necessary, but closer attention to the indicator is required.

Approval:

Once a country’s regulatory authority (for example, the Food and Drug Administration in the United States) approves a new drug application, the new medicine becomes available for physicians to prescribe. The manufacturing company must continue to submit periodic reports to the regulatory authority, including any cases of adverse reactions and appropriate quality control records. For some medicines, the regulatory authority may require additional studies to evaluate long-term effects.

Aseptic Technique:

Specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by microorganisms.

Aseptic Work Area, Clean Work Environment, Work Area, and Critical Work Area:

For the purposes of this procedure, synonymous with biological safety cabinet (BSC), laminar flow hood, clean bench, or other such clean enclosure.

Archive:

A file or place for the orderly storage and expedient retrieval of raw data, documentation, protocols, samples and interim or final reports.

Artwork:

An artwork could be any printing, text illustration, copy, ornamentation or colouring work on a Product’s Packages. This includes also the label, insert, leaflet, carton, shipper, sticker and vignette.

Atypical Result:

An atypical result is a result which could be but must not be outside the pre-defined limit, however the result does not fit to the expectation or the normal distribution of results. These results should be evaluated to predict any trends and to evaluate the significance.

Audit:

An audit is a formal review of the GMP and Quality status of an operation, a facility, a process, a service or system versus the applicable standards and directives.

Auditee:

The Auditee is the organization that is being audited. The Auditee will be responsible for responding in writing to Audit report observations and implementing corrective actions as necessary.

Auditor:

Can be one or more individual(s) who are responsible to support the Audit coordination, the pre-Audit meeting if applicable, the Audit, the final wrap up and Audit report information.

Auditor Lead:

Person assigned by Quality Management who is responsible for assembling the Audit team, Leading the Audit coordination, the pre-Audit meeting if applicable, the Audit, the final wrap up, the Audit report information, writing the Audit report and conducting the follow-up. Typically this is the more senior member of the team.

Authorized Person:

The authorized person in some European countries also called as qualified persons (QP) is the person(s) among key Manufacturing and Quality personnel responsible for GMP compliance and the release of every Batch of final Products.