Expert Working Group submits Comments to the Concept Paper on the revision of EU / PIC/S Annex 11

On 16 November 2022, EMA GMP/GDP Inspector Working Group and PIC/S published for comment the Concept Paper on the revision of Annex 11: Computerised Systems. This Concept Paper shall set scope and, in some extent, the level of detail of Annex 11 R2 and could be commented until 16 November 2023.

In 2022, Annex 11 celebrated already 30 years of existence since its initial version has been released in 1992. A first revision – R1 – has been published in January 2011 after about three years of work.

According to the timetable mentioned in the Concept Paper (Section4), the new version – R2 – should be published in 2026 after a public consultation in early 2025.

Looking back at the experienced revision frequency, it is reasonable to expect that this new revision would remain valid for about 15 to 17 years, i.e. until 2040-2043.

It should be clear for everybody that the content of a regulation related to a rapid changing and evolving topic like Computerised Systems represents a real challenge between:

  • Basic principles which shall remain as stable and reliable as possible
  • Necessary flexibility for supporting innovation (at least not hindering it)
  • Ability to remain open for, today, not already available nor even existing technology.

It is realy like squaring the circle!

Over the decades, it is reassuring to note that the main message and core requirement established since 1992 remains valid:
"Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process."
Obviously it is to expect that this requirement will be slightly updated to enforce the importance of data integrity.

The big challenge for the regulators will be to establish a rigorous approach to ensure consistency between:

  • Regulation, i.e. Annex 11 and Chapter 4, which shall remain as technology agnostic as possible
  • "easy-to-update" Questions & Answers
  • Guidance, for example (still not updated) PI 011-3, PI 041-1, offering support regarding possible implementation and drafting solution
  • Position and Reflection Papers, addressing for instance emerging technology

Surprisingly, the Concept Paper does not cover the expected revision of Chapter 4, nor an equivalent Concept Paper is available for Chapter 4. This situation is highly unfortunate since it shall not conduct to a scope extension of Annex 11 in order to cover Chapter 4 topics as well.

The strategy followed by the Authorities over the last 30 years secures consistency between the both documents, systematically avoiding redundancies.
Since an update of Chapter 4 is as necessary than the update of Annex 11, it would be very appreciated that a similar Concept Paper will be published for comment as soon as possible, otherwise there is a significant risk that inconsistencies and redundancies appear between the both documents.

The ECA Foundation and its European QP Association have set up an international Expert Working Group led by Yves Samson and with, amongst others, the following members:

  • Britta Abellan, Switzerland
  • Frank Behnisch, CSV Lead CSL Behring GmbH, Marburg, Germany
  • Hervé Cluzeaud, EXPLEO, France
  • Quentin Hoyaux, EXPLEO Life Sciences Switzerland
  • Véronique Dagois, CAPE Expert, France
  • Lionnel Lafontaine, Groupe SPC, France
  • Pierre Chabert, Consultys, Belgium
  • Philippe Lenglet, Laboratoires Servier, France
  • Orlando Lopez, Owner of the Annex 11 Group on LinkedIn, USA
  • Bob McDowall, R.D.McDowall Limited, UK
  • Stefan Münch, Business Director Validation, Körber Pharma Consulting GmbH, Germany
  • Michel Raschas, PROGMP, France
  • Georg Roth, Anton Paar GmbH, Graz, Austria
  • Jonathan Schott, Merck, France
  • Rob Stephenson, Robert Stephenson Consultancy, UK

to prepare extensive comments on the Concept Paper. To find out more about the comments that were submitted, please see the following documents.

 Concept Paper on the revision of Annex 11' (EMA/INS/GMP/778340/2022) - Comments from ECA Foundation & European QP Association    

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