Glossary/terms

Glossary/terms

Accreditation: The procedure by which an authoritative body gives formal recognition that a body is competent to carry out specific tasks.

Accuracy: The degree of agreement of a measured value with the actual expected value.

AOAC: Association of Official Analytical Chemists

ASTM: American society for testing and materials.

Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by material measure and the corresponding values of the measurand.

CITAC: Co-Operation on International Traceability in Analytical Chemistry. A forum for worldwide cooperation collaboration on the mechanisms needed to ensure the validity and comparability o analytical data on a global basis.

cGMP: Current Good Manufacturing Practice.

Code of Federal Regulations (CFR) : Collection of all regulations issued by U.S. government agencies. The individual titles making up the regulations are numbered the same way as the federal laws on the same topic. For example, the Federal Food, Drug, and Cosmetic Act is found in Title 21 of United States Code and the companion regulations implementing the law are found in 21 CFR.

Computer system: A system composed of computer(s), peripheral equipment such as disks, printers and terminals, and the software necessary to make them operate together (ANSI/IEEE Standard 729-1983).

Computerized system: A system that has a computer as a major, integral part.

The system is dependent on the computer software to function.

EPA: Environmental Protection Agency of the United States Government. A regulatory body who develops and enforces all aspects of environmental monitoring. This includes development of analytical methods.

EP: European Pharmacopeia, Official compendium of the

member states of the Council of Europe, which includes

all EC and EFTA countries.

FDA: Food and Drug Administration, U.S. agency, part of the Department of Health and Human Services, responsible for regulating clinical research and approval of marketing

permits for food, drugs, medical devices and cosmetics in the U.S.

GALP: Good Automated Laboratory Practice.

GAMP: Good Automated Manufacturing Practice.

GCP: Good Clinical Practice.

GLP: Good Laboratory Practice

GMP: Good Manufacturing Practice.

ICH: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

ILAC: International Laboratory Accreditation Cooperation. Working for international acceptance of data generated by accredited organizations. Developed the ISO Guide 25.

Installation Qualification (IQ): Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.

ISO: International Organization for Standardization. Agency responsible for developing international standards; over 160 technical committees, 650 sub-committees and 1500 working groups; more than 6000 ISO standards published; represents more than 90 countries. Founded in 1947.