A
ACC

The American Chemistry Council

ACC Responsible Care

The American Chemistry Council has implemented Responsible Care, a voluntary program to achieve improvements in environmental, health and safety performance beyond levels required by the U.S. government. Site and Supply Chain Security Overview [6]

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. [13]

Acceptable Daily Intake (ADI)

The amount of a substance that can be ingested daily for an entire lifetime without causing appreciable adverse effects. It is expressed in mg/kg body weight/day. [7]

Acceptance criteria

Numerical limits, ranges or other suitable measures of acceptance for test results. [1, 2, 3, 12]

Accountability

The obligation to account for one?s conduct and actions, usually to an individual or group, but ultimately to the public. Both individuals and organizations may be accountable. There is some overlap between accountability and transparency (see below). [25]

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. [4]

Active Pharmaceutical Ingredient (API)

Any substance or mixture of substances, intended to be used in the manufacture of a drug 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 act

Additive

A substance added to the excipient to improve or maintain a characteristic such as a preservative, flow agent, antimicrobial, etc. [4]

ADI

Acceptable Daily Intake

ADME

Absorption, distribution, metabolism and excretion

Adulterated Material

Material that has been contaminated with either a foreign material or not manufactured using GMP. This does not pertain to a material that simply does not meet physical or chemical specifications. [1]

AEO

Authorised Economic Operator - status applied to organisations in Europe which permits them to regulatory relief from customs inspections and documentary requirements. Akin to C-TPAT in that it also requires supply chain security measures to be implemented.

Aflatoxins

The aflatoxins are a group of structurally related toxic compounds produced by certain strains of the fungi Aspergillus flavus and A. parasiticus. Under favorable conditions of temperature and humidity, these fungi grow on certain foods and feeds, resulting in the production of aflatoxins. The most pronounced contamination has been encountered in tree nuts, peanuts, and other oilseeds, including corn and cottonseed. Aflatoxicosis is poisoning that results from ingestion of aflatoxins in contaminated food or feed. [6]

Agent

A person appointed by a DMF holder to serve as the contact for the holder. [7]

Agreement

Arrangement undertaken by and contractually binding on parties [3, 17, 18]

AIB

The American Institute of Baking

Allergens

A substance that causes an abnormal response by the immune system to certain proteins found in the substance. [6]

Analytical Methods Validation

Documented evidence demonstrating assurance that an analytical method can consistently produce accurate results for the intended analytical performance characteristics.

Analytical Procedure

The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. [14]

Animal Sourced

Contains and/or manufactured with starting materials of animal origin. [6]

Annual Report

A report required to be filed with the US FDA within 60 days of the anniversary of the launch of the product into the US market and which provides a sumary of the activities undertaken relating to the product in question during the proceding year. (See also 21 CFR 314.70(d) and 21 CFR 314.81(b)(2).)

API

Active Pharmaceutical Ingredient

API Starting Material

Any material used in the production of the API to create the significant structural fragment or that is purified to produce the API.

Archival System

System used to preserve information considered necessary for future recall or as a legal obligation, using media suitable for storage and retrieval.

Assay (content or potency)

To provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample. [14]

Audit Team Leader

A qualified individual who organizes, coordinates, and is qualified to conduct audits to requisite standard of operation, as applicable.

Auditable Standard

A system, voluntary or mandatory, that imposes a set of operating conditions or specifications, and that can be confirmed by audit.

Auditing

A documented independent, systematic and objective activity designed to assess, evaluate, examine a process, site or organization.

Auditing Program

The organization of audits to confirm that all or part of an organization remains in compliane with the requisite standard, whether voluntary or mandatory.

Authorized Copy

A copy of a procedure either printed or in an appropriate secured e-format, that has been issued by an orgainzation to a second organization for their use.

Authorized Person

The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country. [20]