Good Automated Manufacturing Practice

The " Good Automated Manufacturing Practice Guide for Validation Supplier of Automated Systems in Pharmaceutical Manufacture" (short: GAMP ) was published in 1995 by the UK Pharmaceutical Industry Computer Validation forum. This guide has become the standard framework for the validation of computerized systems in the pharmaceutical industry ( manufacturers and suppliers ). However, the GAMP regulations have no legal binding. Differing forms of validation of computerized systems which are possible, which is useful for many systems.

In addition to Good Practice Guides are created on specific aspects, such as the Guide "Validation of Process Control Systems ".

Since the end of February 2008, the current version is 5 ( GAMP 5) available. The document must be purchased. In December 2008, this guide ( GAMP 5) was translated into German. Since mid-2009, an electronic version is also available.

Note: Erroneously the GAMP 5 is considered an official policy sometimes. It is a recognized standard as a guideline for validation.

ISPE GAMP 5 Structure

The GAMP 5 document is hierarchical. The validation issues are fully shown in a general section and you will be directed to four main attachments, which treat the individual topics in detail. For a further specialization are below the GAMP Good Practice Guides called 5 more released, which include these issues further.

Good Practice Guides in the series Corol the show ( 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
Validation (drug manufacture)
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