Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS). Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, and other countries.
1 High-level details 2 Guideline versions 3 Enforcement 4 CGMP inspections 5 Other good practices 6 See also 7 References 8 External links
High-level details 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:
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.
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. 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. 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.
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.
World Health Organization
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
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. See also
Corrective and preventive action
^ a b c Institute of Food Science & Technology (2012). Food and
Drink - Good Manufacturing Practice - A Guide to its responsible
management. Wiley-Blackwell. p. 280.
^ a b c d e f Moore, I. (2009). "Chapter 5: Manufacturing Cosmetic
Ingredients According to Good Manufacturing Principles". In Lintner,
K. Global Regulatory Issues for the Cosmetic Industry. Elsevier.
pp. 79–92. ISBN 9780815519645.
^ a b Nally, J.D., ed. (2007). Good Manufacturing Practices for
Pharmaceuticals (6th ed.). CRC Press. p. 424.
^ a b "Guidance for Industry: Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements; Small Entity Compliance Guide". U.S. Food and Drug and
Administration. 12 November 2017. Retrieved 2 February 2018.
^ Ramakrishna, S.; Tian, L.; Wang, C.; et al., eds. (2015). "Chapter
3: Quality management systems for medical device manufacture". Medical
Devices: Regulations, Standards and Practices. Woodhead Publishing
Series in Biomaterials. 103. Elsevier. pp. 49–64.
World Health Organization
Pharmaceutical Inspection Cooperation Scheme: GMP Guides
World Health Organization
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