Glossary

Factory Mutual (Insurance Underwriters)

Fast Moving Consumer Goods

Field Management Directives

Foot and Mouth Disease Virus

Failure Mode and Effect Analysis

Failure Mode, Effect, and Criticality Analysis

Frequency-Modulation Spectroscopy

Any enclosing cluster of cells that protects and nourishes a cell or structure within. Thus a follicle in the ovary contains a developing egg cell, while a hair follicle envelops the root of hair.

A doctor’s or researcher’s examination of patient signs and symptoms after a test or treatment have been given.

The U.S. Regulatory agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services, which, among other responsibilities, evaluates pharmaceutical candidates for safety and efficacy, and determines whether to authorize them to be marketed in the United States. Other countries have similar regulatory agencies that must grant marketing authorization before a drug can be sold there.

Enzyme used to control food texture, flavor, appearance and, to a certain extent, nutritional value. Amylases break down complex polysaccharides to simplex sugars; proteases tenderize meat proteins. Biotechnology can assist the development of new food enzymes by finding or engineering enzymes which fit better with the other processes which the food must undergo, like cooking or canning.

Passed after the Elixir Sulfanilamide tragedy, the Food, Drug, and Cosmetic Act required pharmaceutical manufacturers to submit a New Drug Application to prove the drugs safety. The act also provided the basis for the distinction between prescription and nonprescription drugs that was further developed in the Durham-Humphrey Amendment.

(ICH Q1B) Those undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation.

The use of DNA for identification. Some examples of DNA use are to establish paternity in child support cases; establish the presence of a suspect at a crime scene, and identify accident victims.

Plastically deforming metal, usually hot, into desired shapes with compressive force, with or without dies.

Manufacturers of a new medical device need not file a premarket approval form if the device is “substantially similar” to an already approved device that did not require a premarket approval form. Instead manufacturers may file the simpler form 510(k). The 510(k) was supposed to be a premarket notification that did not require approval. In the years following 1976, the FDA began to require that more and more information be included with the 510(k) notification. Now the industry considers the 510(k) to be the first in a series of premarket approval hurdles, rather than a notification. With the passage of the SMDA in 1990, the 510(k) officially became a premarket approval regulation.

(IEEE) The test, inspection, or analytical process by which a group of configuration items comprising a system is verified to have met specific contractual performance requirements.

(NIST) A specification written and approved in accordance with established standards.

A specification expressed in a requirements specification language.

(ICH Q1A (R2)) Long term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the re-test period of a drug substance or the shelf life of a drug product.

(IEEE) Testing conducted in accordance with test plans and procedures that have been reviewed and approved by a customer, user, or designated level of management. Antonym: Informal Testing.

A colorless, highly irritating, pungent compound used in the pharmaceutical and cosmetic industries as an antimicrobial agent.

System of biocontamination control with established and documented procedures.

The composition of a dosage form, including the characteristics of its raw materials and the operations required to process it.

1. (noun) The chemical and physical composition of a drug product. 2. (verb) The act of compounding a drug product.