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Acronym

Definition



CFIA

Canadian Food Inspection Agency is responsible for verifying that domestically produced and imported products meet Canadian standards and regulations. CFIA regulates veterinary biologics – such as vaccines, antibody products, and in vitro diagnostic test kits that are used for the prevention, treatment, or diagnosis of infectious diseases in animals, including domestic livestock, poultry, pets, wildlife, and fish. Additionally, CFIA works with Agency scientists and technical experts to establish the biocontainment levels, procedures and protocols that are needed to work safely with animal viral and bacterial pathogens, chemical hazards, and plant pests of quarantine significance.



cGMP/GMP

cGMP/GMP are the current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that products are consistently produced and controlled to meet specific quality requirements for their intended use.



FDA

United States Food and Drug Administration is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.



GAMP

Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry



ISPE

International Society for Pharmaceutical Engineering – industry trade group for pharmaceutical science and manufacturing professionals



PIC/S

The Pharmaceutical Inspection Cooperation Scheme are two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.



USDA

United States Department of Agriculture provides leadership on food, agriculture, natural resources, and related issues. The Animal and Plant Health Inspection Service (APHIS) section of the USDA regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective.



USP-NF

USP–NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Compendia contains monographs for drug substances, dosage forms, and compounded preparations and also dietary supplements, ingredients and excipients. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.


GMP Definitions

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