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.
All guidelines follow a few basic principles:[2][6] Good manufacturing practice is recommended with the goal of safeguarding the health of consumers and patients as well as producing quality products.
[1]: "Decision Makers' Summary", [2] Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations.
[12][13][14][15] Courts may theoretically hold that a product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.
[4] Additionally, in the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not necessarily CGMPs.
Similar GMPs are used in other countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines], Vietnam and others having highly developed/sophisticated GMP requirements.
[12][18][21][22][23][24][26][27][28] FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and Cosmetic Act (21 USCS § 374), which requires that they are performed at a "reasonable time".