ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Good Automated Manufacturing Practice (GAMP)

A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.

Publication Source: GAMP® Good Practice Guide: Validation of Process Control Systems

Publication Date: 2003

Good Automated Manufacturing Practice (GAMP)

A technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training seminars for its members.

These guidelines are:

1. GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures

2. GAMP Good Practice Guide: Calibration Management

3. GAMP Good Practice Guide: Electronic Data Archiving

4. GAMP Good Practice Guide: Global Information Systems Control and Compliance

5. GAMP Good Practice Guide: IT Infrastructure Control and Compliance

6. GAMP Good Practice Guide: Validation of Laboratory Computerized Systems

7. GAMP Good Practice Guide: Validation of Process Control Systems

8. GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems

9. GAMP Good Practice Guide: Legacy Systems

10. GAMP Good Practice Guide: Testing of GxP Systems

Publication Source: Food and Agricultural Organization of the United Nations (FAO)
Publication Date: 1999

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