#regulation Tag


GAMP®5, now supplemented by several Good Practice Guides, is a globally accepted standard for the validation of computerised systems.

The progress of IT environments in recent years has made it necessary to revise and extend the guide, although the basic structure is still well suited to the current IT landscape and to the validation of computer systems.

The new edition “GAMP®5 2nd Edition” is not a new guideline but a revision of the existing guide. It was published at the end of July 2022 and can be ordered on the ISPE website. (https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition).


What are the news in the GAMP®5 2nd edition?

The structure, divided into 8 chapters, has remained unchanged:

  • 1-Introductio
  • 2-Key Concepts
  • 3-Life Cycle Approach
  • 4-Life Cycle Phases
  • 5-Quality Risk Management
  • 6-Regulated Company Activities
  • 7-Supplier Activities
  • 8-Efficiency Improvements


  • In the chapter 3-Life Cycle Approach, the subsection “Critical Thinking Through the Life Cycle” has been added,
  • 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 D2 “Functional Specifications” has been removed and for new Appendices have been introduced:
    • D8 “Agile Software Development“,
    • D9 “Software Tools“,
    • D10 “Distributed Ledger Systems (Blockchain)“,
    • D11 “Artificial Intelligence and Machine Learning (AL/ML)“.
  • In the Operation Appendices, besides some wording adjustments, the Appendix O7 “Repair Activity” has been removed.
  • In the Special Topics Appendices, Appendix S5 “Managing Quality within an Outsourced IS/IT Environment” has been removed.
  • In the General Appendices, the previous Appendix G1 “GAMP Good Practice Guide Summary” has been removed.

The European Commission has decided to revise Annex 1 of the EU GMP “Manufacture Of Sterile Medicinal Products” to cover the current regulatory and technological developments in the manufacture of sterile medicinal products. In particular, the integration concerns some aspects addressed in ICH guidelines Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

The Final Version of Annex 1 was published on 25 August 2022.



  • New Annex 1 will come into force on 25 August 2023
  • Chapter 8.123 “Lyophilizers and associated product transfer and loading/unloading areas” will come into force on 25 August 2024


Changes compared to the second draft version of 2020

The basic structure of Annex 1 has remained unchanged.

In this final version, are broadened topics such as:

  • “Barrier Technologies” – subchapter of the chapter “Premises”
    • The topics of background environment, gloves and decontamination methods have been dealt with separately for Isolators and RABS: “18 Isolators or RABS, which are different technologies, and the associated processes, should be designed to provide protection through separation of the grade A environment from the environment of the surrounding room. […]”
  • “Form-Fill-Seal (FFS)” (8.96) and “Blow-Fill-Seal” (8.105) – subchapter of the chapter “Production and Specific Technologies” go into much more detail.
  • In addition, there are new insertions in many chapters, as well as deletions and rewording.