11 August 2022

Revised GAMP®5 guidelines published

Billev Pharma East experts can support you during qualification and validation activities related to development and implementation activities of computerised systems in GMP and GDP environment.

GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.

What has changes or has been added in GAMP®5 2nd Edition:

  • in the chapter 3-Life Cycle Approach, the subsection “Critical Thinking Through the Life Cycle” has been added, and in the chapter 8-Efficiency Improvements, the subsection “Using Tools and Automation” has been included in addition to some wording adjustments;
  • in the management appendices, the appendices M 11 “Infrastructure” and M 12 “Critical Thinking” have been added as well as some minor changes in the wording;
  • in the Development Appendices, in addition to some wording changes, Appendix D 2 “Functional Specifications” has been removed and 4 new appendices have been introduced – D 8 “Agile Software Development”, D 9 “Software Tools”, D 10 “Distributed Ledger Systems (Blockchain)”, D 11 “Artificial Intelligence and Machine Learning (AL/ML)”;
  • in the Operation Appendices, besides some wording adjustments, the appendix O 7 “Repair Activity” has been removed;
  • in the Special Topics Appendices, Appendix S 5 “Managing Quality within an Outsourced IS/IT Environment” has been removed;
  • in the General Appendices, the previous Appendix G 1 “GAMP Good Practice Guide Summary” has been removed.