Good Manufacturing Practice

High-level details[edit]
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality
assurance in order to ensure that a manufactured product is safe for human consumption or use.
Many countries have legislated that manufacturers follow GMP procedures and create their own
GMP guidelines that correspond with their legislation.
All guideline follows a few basic principles[2][6]:
 Manufacturing facilities must maintain a clean and hygienic manufacturing area.

 Manufacturing facilities must maintain controlled environmental conditions in order to
prevent cross-contamination from adulterants and allergens that may render the product unsafe
for human consumption or use.
 Manufacturing processes must be clearly defined and controlled. All critical processes
are validated to ensure consistency and compliance with specifications.
 Manufacturing processes must be controlled, and any changes to the process must be
evaluated. Changes that affect the quality of the drug are validated as necessary.
 Instructions and procedures must be written in clear and unambiguous language using good
documentation practices.
 Operators must be trained to carry out and document procedures.
 Records must be made, manually or electronically, during manufacture that demonstrate that all
the steps required by the defined procedures and instructions were in fact taken and that the
quantity and quality of the food or drug was as expected. Deviations must be investigated and
documented.
 Records of manufacture (including distribution) that enable the complete history of a batch to be
traced must be retained in a comprehensible and accessible form.
 Any distribution of products must minimize any risk to their quality.
 A system must be in place for recalling any batch from sale or supply.
 Complaints about marketed products must be examined, the causes of quality defects must be
investigated, and appropriate measures must be taken with respect to the defective products
and to prevent recurrence.
Good manufacturing practices are recommended with the goal of safeguarding the health of
consumers and patients as well as producing quality products. In the United States, a food or drug
may be deemed "adulterated" if it has passed all of the specifications tests but is found to be
manufactured in a facility or condition which violates or does not comply with current good
manufacturing guideline.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series
of general principles that must be observed during manufacturing. When a company is setting up its
quality program and manufacturing process, there may be many ways it can fulfill GMP
requirements. It is the company's responsibility to determine the most effective and efficient quality
process that both meets business and regulatory needs.[1][2]
Guideline versions[edit]
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under
Title 21 CFR. The regulations use the phrase "current good manufacturing practices" (CGMP) to
describe these guidelines.[7][8][9][10] 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.[11] However, since June 2007, a different set of CGMP
requirements have applied to all manufacturers of dietary supplements, with additional supporting
guidance issued in 2010.[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.[9]
The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and
the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world.
[3]
The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the
FDA's version in the US. 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] 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.[13]
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.[12]
Enforcement[edit]
Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP
inspections are performed in Canada by the Health Products and Food Branch Inspectorate [14]; the
United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA))[15]; in the
Republic of Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS)[16]; in Australia by
the Therapeutic Goods Administration (TGA)[17]; in Bangladesh by the Directorate General of Drug
Administration (DGDA)[18]; in South Africa by the Medicines Control Council (MCC)[19]; in Brazil by
the National Health Surveillance Agency (ANVISA)[20]; in India by state Food and Drugs
Administrations (FDA), reporting to the Central Drugs Standard Control Organization[21]; in Pakistan
by the Drug Regulatory Authority of Pakistan[22]; in Nigeria by NAFDAC[23]; 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.
CGMP inspections[edit]
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. [7][13][16][17][18][19]
[21][22][23]
FDA routine domestic inspections are usually unannounced, but must be conducted according
to 704(a) of the FD&C Act (21 USCS § 374), 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.[24]
Other good practices[edit]

Other good-practice systems, along the same lines as GMP, exist:
 Good agricultural practice (GAP), for farming and ranching

 Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new
drugs in humans
 Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal
products for human use
 Good laboratory practice (GLP), for laboratories conducting non-clinical
studies (toxicology and pharmacology studies in animals)
 Good pharmacovigilance practice (GVP), for the safety of produced drugs
 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 guidance practices, and good
tissue practices.

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High-level details[edit]

 Manufacturing facilities must maintain a clean and hygienic manufacturing area.

Other good practices[edit]

 Good agricultural practice (GAP), for farming and ranching

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