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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.
1950s-1970s: Developed baking certification programs and ingredient testing protocols. 1980s-1990s: Introduced food safety training, GMP inspections, and HACCP auditing. 2000s-Present: Became a leader in global food safety certifications, offering compliance programs aligned with GFSI, FDA, and ISO 22000 standards.
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 ]
The Codex Alimentarius (Latin for 'Food Code') is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization (FAO) and World Health Organization (WHO) of the United Nations relating to food, food production, food labeling, and food safety.
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.
Pillsbury's training program, which was submitted to the FDA for review in 1969, entitled "Food Safety through the Hazard Analysis and Critical Control Point System" was the first use of the acronym HACCP. [5] HACCP was initially set on three principles, now shown as principles one, two, and four in the section below.
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...
According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. [5]