Glossary

A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant 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.

(ICH Q7) 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.

Active Pharmaceutical Ingredients Committee of CEFIC

Association of the Portuguese Pharmaceutical Industries

To be without breath or respiration. Transient cessation of respiration.

The protein moiety of an enzyme - determines the specifity of the enzyme reaction.

Certain alleles of the gene that encodes the protein apolipoprotein E have been associated with the development of heart disease and Alzheimer’s disease.

The process of cell death, which occurs naturally as a part of normal development, maintenance and renewal of tissue in an organism. Apoptosis differs from necrosis, in which cell death is caused by a toxic substance.

Amyloid Precursor Protein

The person of company that submits an application for marketing authorization of a new pharmaceutical product, an update to an existing marketing authorization, or a variation to an existing marketing authorization.

The initial owner of the data before it is archived.

(ISO) Software or a program that is specific to the solution of an application problem.

Any executable program developed or modified specially for customer applications.

(IEEE) Software designed to fill specific needs of a user; for example, software for navigation, payroll, or process control.

Archivists’ term. The purpose of archival appraisal is to decide which records should be preserved in the long term. As the term appraisal indicates, it should reveal the value of the records for future purposes and retention decisions should be based on that value.

Someone using the authorization code, usually user ID and password of another person to secure access to network resources for which he or she does not have privileges or authorization. Can be intentional or not. CFR 21 Part 11 mandates technical controls that prevent this.

Persons who have been trained and their competence assessed to a suitable level of expertise to carry out defined activities.

(in relation to institutional review boards). The affirmation decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements.

Annual Product Review

Short strands of DNA that bind protein targets.