GMPs are enforced in the United States by the US FDA, under Section 501(B) of the
1938 Food, Drug, and Cosmetic Act (21USC351). The regulations use the phrase "current
good manufacturing practices" (cGMP) to describe these guidelines. Courts may theoretically
hold that a drug 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.[citation needed] As of June 2010, the same CGMP requirements
apply to all manufacturers of dietary supplements.
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators
and the pharmaceutical industry in over one hundred countries worldwide, primarily
in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements
to WHO GMP, as does the Food and Drug Administration's version in the US. Similar
GMPs are used in other countries, with Australia, Canada, Japan, Singapore and others
having highly developed/sophisticated GMP requirements. In the United Kingdom, the
Medicines Act (1968) covers most aspects of GMP in what is commonly referred to
as "The Orange Guide", which is named so because of the color of its cover; it is
officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.
Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the
International Conference on Harmonization (ICH), GMPs now apply in those countries
and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and
applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH
guidelines for the manufacture and testing of active raw materials.
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Within the European Union, GMP inspections are performed by National Regulatory
Agencies (e.g., GMP inspections are performed in the United Kingdom by the Medicines
and Healthcare products Regulatory Agency (MHRA)); in the Republic of Korea (South
Korea) by the Korea Food and Drug Administration (KFDA); in Australia by the Therapeutical
Goods Administration (TGA); in South Africa by the Medicines Control Council (MCC);
in Brazil by the Agência Nacional de Vigilância Sanitária (National Health Surveillance
Agency Brazil) (ANVISA); in Iran, India and Pakistan by the Ministry of Health;[3]
and by similar national organisations worldwide. Each of the inspectorates carry
out routine GMP inspections to ensure that drug products are produced safely and
correctly; additionally, many countries perform pre-approval inspections (PAI) for
GMP compliance prior to the approval of a new drug for marketing.
Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many
European nations) are authorized to conduct unannounced inspections, though some
are scheduled. FDA routine domestic inspections are usually unannounced, but must
be conducted according to 704(A) of the FD&C Act (21USC374), which requires
that they are performed at a "reasonable time". Courts have held that any time the
firm is open for business is a reasonable time for an inspection
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Other good-practice systems, along the same lines as GMP, exist:
- Good laboratory practice (GLP), for laboratories conducting non-clinical studies
(toxicology and pharmacology studies in animals);
- Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies
on new drugs in humans;
- Good regulatory practice (GRP), for the management of regulatory commitments, procedures
and documentation.
Collectively, these and other good-practice requirements are referred to as "GxP"
requirements, all of which follow similar philosophies. (Other examples include
good agriculture practices, good guidance practices, and good tissue practices.)
In the U.S., medical device manufacturers must follow what are called "quality system
regulations" which are deliberately harmonized with ISO requirements, not cGMPs.