GOOD MANUFACTURING PRACTICES (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products . These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United States, Canada, Europe, China, and other countries.
* 1 High-level details * 2 Guideline versions * 3 Enforcement * 4 cGMP Software solution providers * 5 Other good practices * 6 See also * 7 References * 8 Sources * 9 External links
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
All guidelines follow a few basic principles:
* Manufacturing facilities must maintain a clean and hygienic manufacturing area. * Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption. * Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. * Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that affect the quality of the drug are validated as necessary. * Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices ) * Operators are trained to carry out and document procedures. * Cross contamination with unlabelled major allergens is prevented. * Records are made, manually or by instruments, 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 are investigated and documented. * Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. * The distribution of the food or drugs minimizes any risk to their quality. * A system is available for recalling any batch from sale or supply. * Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
Practices are recommended with the goal of safeguarding the health of consumers and patients as well as producing good quality food, medicine, medical devices, or active pharmaceutical 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. Therefore, complying with GMP is mandatory in all pharmaceutical manufacturing, and most food processing.
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 fulfil GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.
The quality is built into the product and GMP is the most essential part of ensuring this product quality.
GMPs are enforced in the
World Health Organization
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,
GMC is part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization or product specification.
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 Ministry of
Food and Drug Safety (KFDA); in
CGMP SOFTWARE SOLUTION PROVIDERS
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">
* ^ "FDA Issues Dietary Supplements Final Rule" (Press release). U.S. Food and Drug Administration. 2007-06-22. Retrieved 2010-06-04. * ^ Pharmaceutical Press. "Rules and Guidance for Pharmaceutical Manufacturers and Distributors - Edition: 2007" Retrieved 2010-03-01.
* 21 CFR Parts 210/211 Drug GMPs * Pharma GMP Guidelines * GMP Audit