GMP Glossary & Definitions

GMP Calibration:

Calibration is called the process that verifies that under specified conditions, the relationship between values indicated by an instrument or system for measuring, recording, or controlling meets the corresponding known values of a Reference Standard.

or

The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.

 

GMP CAPA:

Corrective and Preventive Action, a written plan describing actions to be taken to address an issue, plan must include implementation steps and target dates.

Certificate of Analysis (CoA):

CoA is the listing of testing results found during the analysis of a Sample which was taken by a defined procedure, of a Batch of Drug Product or Drug Substance/Active Pharmaceutical Ingredient, raw material, components etc.

Certificate of GMP Conformance:

The Certificate of GMP Conformance is a signed document demonstrating that the item was made in conformance with GMPs and all applicable procedures.

CFR:

Code of Federal Regulations

Change Control (click here to see the process description):

Change Control is process in a formal change control system by which qualified representatives of appropriate disciplines review and approve a change request. The review and approval includes the assessment weather the change request might affect a validated or registered status.

Chemical Component:

A Chemical Component is defined as any Chemical Substance not mattering if active or inactive, of a defined Quality used in the manufacture of Bulk Materials, Intermediate or Final Product, whether or not it is present in the Finished Product.

Chemistry, Manufacturing and Control Documentation (CMC Documentation):

CMC documentation is the Chemistry, Manufacturing and Control Documentation section of a Drug Substance / Active Pharmaceutical Ingredient (API) or Drug Product registration.

Chemical reaction:

A process that involves a chemical transformation of a starting material or intermediate to form a new compound (e.g., bond formation, oxidation, reduction).

CIP:

Clean In Place is a method of cleaning installed pipe and equipment without having to dismantle or move the pipe and equipment. However, provisions should be made for partial disassembly or for personnel access for purposes of cleaning validation to facilitate inspection and sampling of inner product surfaces for possible residue or contaminates.

Classified Area:

A classified area is called a room, suite or plant which is dedicated to a defined category of activity, where the viable and non-viable particulate levels, airflows, number of air changes and pressure differentials are monitored, checked, and tested to specified limits.

Clean Area (Room):

The clean area is an area with predefined environmental control following the applicable standards of e.g. particulate and microbial contamination. The clean area should be constructed and used reducing the introduction, generation and retention of contaminants within the area.

Cleaning agent:

Any material used to clean process equipment, utensils, and storage vessels. These may include soaps, detergents, surfactants, alkalis, acids, or other materials, such as organic solvents, if the solvent is specifically used for cleaning and is not a solvent used in the next processing step.

Climatic Zone:

The climatic zones into which the world is divided based on the prevailing annual climatic Conditions (ICH stability conditions).

Clinical:

Denotes the symptoms and course of a disease as distinguished from the laboratory findings or anatomical changes.

Clinical investigator:

Experienced clinical researcher who implements a clinical study protocol with patients.

Clinical pharmacologist:

One who has undergone training in basic pharmacology of therapeutic agents in the prevention, treatment and control of disease in man.

Clinical response:

Any response by a patient to therapy. A positive response can be either complete, in which all signs or symptoms of the disease improve or partial, in which at least one half of the signs or symptoms of a disorder improve and no new signs appear.

Clinical trial or clinical study:

Testing in which preventive, diagnostic, or therapeutic agents are given to a human population under controlled conditions to determine the agents’ safety and effectiveness. This systematic investigation tests the effects of materials or methods, according to a formal study plan (that is, a protocol), usually in subjects having a particular disease or class of diseases. These trials are conducted to satisfy the regulatory requirements to obtain marketing approval for a new drug or for a new indication for a drug previously approved for marketing. In the United States, must be under an approved investigational new drug application, under the guidance of an Institutional Review Board, and in accordance with the Food and Drug Administration’s (FDA) rules on human studies and informed consent of participants. These studies are conducted in three phases: Phase I, Phase II and Phase III.

CMO - Contract Manufacturing (CMO)

Organisation A company that carries out the manufacture of marketed or investigational pharmaceutical products for its clients

Complaint (product):

A Complaint by a customer is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Product (or device) on the market.

or

Means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

GMP Complaint File:

The Complaint File is the documented investigational result including any responses to complainant or authority about a complaint from a released product.

Component:

A Component is any ingredient intended which should be used in the manufacture of a drug product or medical device. This includes those that may not appear in such Drug Product or any Packaging Material containing the Product.

or

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 material.

Computer System:

A Computer System is defined as a system including the input of data, electronic processing and the output of information. This information can than be used for reporting or automatic control.

Commissioning:

Commissioning can be subdivided into three major activities; installation, operation and performance qualifications. It is a formal, written procedure to the planning, executing and documenting of facility validation. This process may include environmental compliance checks, verification of personnel protection equipment and qualification of containment systems as well as validation of systems related to cGMP regulations.

Component:

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.

Concurrent validation:

A subset of prospective validation in which API batches are released for distribution, based on extensive testing, before completion of process validation. Once data from additional batches produced under replicated conditions show uniformity, the process may be considered validated.

Continuous production:

A process in which a material is continuously produced in a step or series of steps. In a continuous process, the batches of raw materials and the process parameters can be statistically, but not absolutely, correlated to the material produced in a given period of time.

Container/Closure System:

The Container/Closure System is defined as the complete package that holds and protects the Product.

Contamination:

Contamination is defined as the presence of impurities of a chemical or microbiological nature or of foreign matter, into or onto a Material.

or

The introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (e.g., occurring during production, sampling, packaging or repackaging, storage or transport).

Containment:

Achieving a level of control over a raw material, intermediate, or API that provides proper protection of these materials from external contamination and cross-contamination.

Contract Research Organisation (CRO)

A company that offers clients pharmaceutical research services, including product development and formulation, clinical trial management, laboratory services, and preparation of regulatory submissions.

Control Number:

Means 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 product can be determined.

Controlled study or controlled trial:

Clinical testing in which one group of subjects is used as a standard of comparison to determine the usefulness of a new medical approach. In a controlled study, doctors give the new drug being tested to one group of subjects, called the "treatment group." They give another drug, or no drug, to a second group of people under the same conditions. This group is often called the "control group." Researchers then compare the results of the two groups.

Corrective Actions:

The corrective action is the action necessary to recover the product / process / material / system, affected by the deviation.

Counterfeit Drugs:

Counterfeit Drugs are Drugs which are deliberately and fraudulently mislabelled. The same applies for drugs manufactured deliberately and fraudulently with respect to identity and/or source.

Critical Equipment / Instrumentation:

Critical Equipment / Instrumentation is defined as Equipment / Instrumentation used in a Process that has a direct impact on the Quality, safety, purity or efficacy of Final Product, or are stated as such in Regulatory Dossiers.

Critical Parameters:

Critical Parameters are parameters used in a Process that have a direct impact on the Quality, safety, purity or efficacy of Final Product, or are stated as such in Regulatory Dossiers.

Critical process parameters:

Process parameters that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity.

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.

Cross-contamination:

A contamination of a material or product with another material or product.