Good Manufacturing Practice
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Good Manufacturing Practice is an international set of guidelines by which drugs and medical devices are manufactured.
The purpose of GMP is to ensure a quality product. Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, GMP takes the tactic of regulating and documenting the production environment itself. If the documentation is not correct and in order, showing how the product was made in a recipe format, and allowing for tracebility in the event of future problems, then the product is considered contaminated.
GMP is used by pharmaceutical production plants in all countries that are participating in the International Conference on Harmonisation, or ICH. Similar forms of GMP may be used in additional countries. Other systems, along the same lines as GMP, exist for laboratories conducting non-clinical studies (GLP), safety (GSP), etc. GMP is also referred to as cGMP, meaning "current".
In the United States, the FDA or Food and Drug Administration sets GMP policy through the mechanism of the Federal Register, and numerous guidelines it releases to industry. The US GMPs are a combination of the legislation (principally 21CFR part 210 and 211), current industry best practice and the current FDA thinking. Consequently GMP is always moving ahead as each company improves.
In Europe GMP is defined in [Commission Directive] 2003/94/EC. Guidelines have been produced to assist manufacturers in complying, these are included in a collection called Eudralex.
One major difference in the EU is that there is a role called a Qualified Person who takes personal responsibility to certify that each batch of product has been produced according to GMP before it is sold.
See also
External links
- ICH Website (http://www.ich.org) (see guideline Q7a)
- FDA Website (http://www.fda.gov/)
- CDER Guidance Documents (http://www.fda.gov/cder/guidance/guidance.htm) (see CGMPs)
- CFR Title 21 Database Search (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm) (Code of Federal Regulations)
- Good Manufacturing Practices - Quality systems - The Good Manufacturing Practice (GMP - Quality System Regulation) Final Rule (http://www.fda.gov/cdrh/comp/gmp.html)
- EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice (http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm)
- GMP Training from CompuPharma (http://www.compupharma.net)
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