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Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4] GAMP published its first guidance in 1994.
Good manufacturing practice (GMP) Best practice; American National Standards Institute (ANSI) Institute of Electrical and Electronics Engineers (IEEE) European Medicines Agency (EMEA) Food and Drug Administration (FDA) Ministry of Health, Labour and Welfare (Japan) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation ...
BTEC opened in fall 2007 and was the first facility dedicated to biomanufacturing training. [7] BTEC is 82,500 gross square feet and contains 63,000-gross square feet of laboratories, which range from small or bench scale to large-scale suites that simulate a biomanufacturing pilot plant capable of producing biopharmaceutical products.
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
S88, shorthand for ANSI/ISA88, is a standard addressing batch process control.It is a design philosophy for describing equipment and procedures. It is not a standard for software and is equally applicable to manual processes.