GMP Glossary & Definitions

International Committee on Harmonisation (ICH):

The international body responsible for harmonising worldwide regulatory requirements for pharmaceuticals

Identified impurity:

An impurity for which a structural characterization has been achieved.

 

Inactive ingredient:

Any component other than an "active ingredient".

Indications:

Treatments that a drug will address. Approved indications are those that government regulators have accepted based on clinical testing. Only these indications may be marketed and offered for sale to the public, although physicians may prescribe drugs for unapproved indications according to their professional judgment.

Informed consent:

The process by which patients learn about and document their understanding of the purpose and procedures of a clinical trial and their agreement to participate in that trial.

Investigational Medicinal Product:

The dosage form to be tested in a clinical trial, along with any placebo or comparator products

Impurity:

Any component of an API that is not the entity defined as the API

Impurity profile:

A description of the identified and unidentified impurities present in an API.

Immediate Action:

An immediate action is the action taken at the time of an occurrence to:
Make the process / product / system / material safe and secure, and/or
Contain effects of event, and / or
Prevent further deterioration and / or
Correct the event.

Incident (minor deviation):

An incident is defined as an unplanned event or deviation from SOP that if occurs probably does not have potentially impact on the safety, quality, purity, identity or efficacy of the API, drug product, medical device or material.

Inspection:

The process undertaken by an Inspector/Investigator to review the company facilities and/or systems.

Inspection Coordinator:

A representative of the company, typically the QA Manager, assigned responsibility for preparing for the inspection, escorting the Inspector/Investigator and facilitating the inspection while the Inspector/Investigator is on the company premises.

Inspection File:

A compilation of documents pertaining to the inspection. This may include, but is not limited to forms and letters from inspecting parties, inspection report, inspection notes, Evidential Materials List, evidential material or reference to location, list of assigned corrective actions, meeting minutes, sample submission forms, and other inspection supported and related materials.

Inspection Report:

A document issued by the Inspector/Investigator that describes the scope of the inspection and any observations resulting from the inspection.

Inspection Runner:
:
A representative of the company that accompanies the Inspector/Investigator, Inspector/Investigator Coordinator, and Scribe while touring the facilities. The runner will convey requests and any other needed actions to the Evidential Material Coordinator.

Inspection Scribe:

:A representative of the company assigned responsibility for taking detailed notes during an Inspection.
Inspection Team:
Company personnel that are directly involved in the inspection. Typically this is the Inspection Coordinator, Scribe, Runner, Subject Matter Experts, Evidential Material Coordinator, Department Managers from the areas that were inspected, and the Head of Regulatory Affairs.

Investigation:

An investigation is the systematic process by which an incident is examined to determine:
•          The immediate cause, conditions or situation
•          The root cause
•          The overall impact on API, drug product, medical device or material
•          The need for any action required to prevent reoccurrence
The investigation of the root cause should be understood and documented normally after 30 working days.

Impurity Profile:

An impurity profile is defined as the description of the identified and unidentified impurities present.

In-Process Control (IPC):

In-Process Control are commonly understood as checks being performed during a Production process for the purpose of monitoring and if necessary, to adjust the process to assure that the Product conforms to its specifications. They are usually part of the registration file.

or

Testing and activities performed during production to monitor and, if necessary, adjust the process.

In-Process Materials:

In-Process Materials are defined as materials which are only partly manufactured and will undergo further operations before it becomes a final product.

or

Any material manufactured, blended, or derived by chemical reaction that is produced for, and used in, the preparation of an API.

Installation Qualification (IQ):

The Installation Qualification (IQ) is defined as the performed and documented operations to ensure that facilities, utilities, equipment and systems are installed as designed and specified.

or

Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

Institutional Review Board (IRB):

A group of doctors, science experts, clergy and others in the US who review and approve the performance of each clinical study at their institution. Each hospital doing the research must have a review board. This board makes sure that the study protects patient safety in light of the potential benefit that it may bring. IRB is the term used in the United States, but the committee is more frequently referred to as an "ethics committee" in other markets.

Instrumentation:

Instrumentations are devices and linkages used to control, measure, calibrate, record or alarm a process, equipment or service function.

Intermediate:

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

ISO:

International Standards Organization

Investigational New Drug (IND) application:

The document that a sponsor (usually a drug company) must submit to the FDA before beginning testing of a new drug on humans. This IND application contains the plans for the clinical for the clinical studies and gives a complete picture of the drug, including its structural formula, animal test results, and manufacturing information. The IND application contains information resulting from several years of research and testing.

In vitro:

Latin phrase meaning "in glass". It refers to a process, test or procedure in which something is measured, observed or produced outside a living organism after extraction from the organism. In vitro studies are carried out in animals or humans.

In vivo:

Latin phrase meaning "in the body". Referring to a biological process or experiment occurring or carried out in the living organism. In vivo studies are carried in animals or humans.