Difference between revisions of "Good Automated Manufacturing Practice"
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Revision as of 23:33, 2 March 2012
Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.[1] One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product.
History
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems.[2] GAMP published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognized good practice worldwide.[3]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP 5) was released in February 2008.[4]
External links
References
- ↑ "ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP)". International Society for Pharmaceutical Engineering. 25 September 2011. http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29. Retrieved 28 February 2012.
- ↑ Smith, Paul (1 December 2008). "20th Anniversary Special Feature: Validation and qualification". Pharmaceutical Technology Europe 20 (2). http://www.pharmtech.com/pharmtech/Validation/20th-Anniversary-Special-Feature-Validation-and-qu/ArticleStandard/Article/detail/574642. Retrieved 28 February 2012.
- ↑ DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling (11 March 2008). "GAMP Standards For Validation Of Automated Systems". Pharmaceutical Processing. http://www.pharmpro.com/Articles/2008/03/GAMP-Standards-For-Validation-Of-Automated-Systems/. Retrieved 28 February 2012.
- ↑ "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems". International Society for Pharmaceutical Engineering. http://www.ispe.org/gamp5. Retrieved 28 February 2012.
