Good automated manufacturing practice
Good Automated Manufacturing Practice (GAMP) is a technical sub-committee, known as a COP (Community Of Practice) of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP COP organizes discussion forums for its members. ISPE organises GAMP related training courses and educational seminars. Several local GAMP COPs, such as GAMP Americas, GAMP Nordic, GAMP DACH (Germany, Austria, Switzerland), GAMP Francophone, GAMP Italiano and GAMP Japan bring the GAMP community closer to its members, in collaboration with ISPE's local Affiliates in these regions.
GAMP guidelines
The GAMP publishes a series of Good Practice Guides for its members on several topics involved in drug manufacturing. The most well-known is the The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP5) was released in January 2008.
Other guidelines are:
- GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
- GAMP Good Practice Guide: Calibration Management
- GAMP Good Practice Guide: Electronic Data Archiving
- GAMP Good Practice Guide: Global Information Systems Control and Compliance
- GAMP Good Practice Guide: IT Infrastructure Control and Compliance
- GAMP Good Practice Guide: Testing of GxP Systems
- GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
- GAMP Good Practice Guide: Validation of Process Control Systems
History
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving FDA expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems. Since 1994, the organization entered into a partnership with the ISPE and published its first GAMP guidelines.
See also
- Corrective and Preventative Action (CAPA)
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
- Validation (drug manufacture)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- European Medicines Agency (EMEA)
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Japan Pharmaceutical Manufacturers Association (JPMA)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
External links
External links
- [1] IT Pharma Validation Europe
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