GAMP Guidance
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 (GAMP5) was released in February 2008.
Other publications in the GAMP series include:
- GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
- 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
Read more about this topic: Good Automated Manufacturing Practice
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