GAMP 5 Guide 2nd Edition Release

In July 2022, 14 years after its first release, ISPE published the second edition of the GAMP® 5 Guide, “A Risk-Based Approach to compliant GxP Computerized Systems.”

The GAMP 5 Guide is a globally recognized and accepted standard for the validation of computerized systems and has been the basis for system validation within the Pharmaceutical industry. Since its first release it has been supplemented by some technical guides, with the goal of deepening the GAMP 5 coverage. The additional guides, together with the continuous technological evolution, have created the need for a GAMP 5 update to the second version. As stated by ISPE Board Chair Jörg Zimmermann in April 2022:

“The primary purpose and objective of this revision is the publication of a GAMP 5 Second Edition, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5 Guide: Records and Data Integrity, acknowledgment of current FDA work on Computer Software Assurance (CSA), and an updated, dynamic, and evolving set of Appendices.”

While the overall approach, framework, and key concepts of the Guide remain unchanged, the technical content has been updated mainly to reflect:

  • The increased importance of IT service providers, including cloud service providers;
  • Evolving approaches to software development including incremental and iterative models and methods;
  • Increased use of software tools and automation to achieve greater control, higher quality and lower risks throughout the life cycle.
  • The application of new technological areas such as Artificial Intelligence and Machine Learning (AI/ML), Blockchain, cloud computing, and Open-Source Software (OSS);
  • Introduction of concepts of computerized systems assurance and critical thinking.

With the GAMP 5.2 release, updates in procedures and processes are expected. PQE Group can provide support to your business and ensure the full compliance of your computerized systems. Our services portfolio guarantees a comprehensive solution to cover all of your needs with a Glocal approach, as we work at a local level with a global mindset. We offer:

  • Webinars and trainings to educate your workforce on the new concepts of the recent release
  • Support for integrating new concepts and methodologies in your QMS:
  • Workshops, Assessment & Gap Analysis oriented to prepare the update of the QMS
  • New procedures writing and/or updating existing ones
  • Support for the application of new concepts to real (pilot) projects, systems, equipment and infrastructures

Visit our CSV & Data Integrity page or get in touch with our team to explore a customized solution for your needs.