Good Automated Manufacturing Practice
The " Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture" (GAMP for short) was published in 1994 by the Pharmaceutical Industry Computer Systems Validation Forum (PICSVF), which was later renamed the Good Automated Manufacturing Practice Forum (GAMP) , published in collaboration with the International Society for Pharmaceutical Engineering (ISPE). This guideline has become the standard set of rules for the validation of computerized systems in the pharmaceutical industry (manufacturers and suppliers). However, the GAMP regulations are not legally binding. Therefore, different forms of validation of computerized systems are possible, which is useful for many systems.
In addition, Good Practice Guides are created on special aspects, for example the “Validation of Process Control Systems” guide.
The current version 5 (GAMP 5) has been available since the end of February 2008. The document must be purchased. In December 2008, this guide (GAMP 5) was translated into German. An electronic version has also been available since mid-2009.
Note: GAMP 5 is sometimes mistakenly viewed as an official guideline. It is a recognized standard as a guide for validation.
ISPE GAMP 5 structure
The GAMP 5 document is structured hierarchically. The validation topics are presented in full in a general section and reference is made to four different main annexes, which deal with the individual topics in detail. For a further specialization, further so-called Good Practice Guides are published below GAMP 5, which further contain these topics.
Good Practice Guides in the order in which they are published (list is not complete and will not be updated):
- GAMP Good Practice Guide: Calibration Management
- GAMP Good Practice Guide: Validation of Process Control Systems (new version planned for 2009)
- GAMP Good Practice Guide: Validation of Legacy Systems
- GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
- GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
- GAMP Good Practice Guide: IT Infrastructure Control and Compliance
- GAMP Good Practice Guide: Global Information Systems Control and Compliance
- GAMP Good Practice Guide: Testing of GxP Systems
- GAMP Good Practice Guide: Electronic Data Archiving
See also
Web links
Individual evidence
- ^ Smith, Paul: 20th Anniversary Special Feature: Validation and qualification . In: Pharmaceutical Technology Europe . 20, No. 2, December 1, 2008. Retrieved March 1, 2015.
- ↑ DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling: GAMP Standards For Validation Of Automated Systems . Pharmaceutical Processing. March 11, 2008. Archived from the original on May 8, 2012. Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. Retrieved February 28, 2012.
