EMEA Publishes Concept Paper on Annex 11 - Computerised Systems

GMP News No. 869

GMP News
16 January 2007

EMEA Publishes Concept Paper on Annex 11 - Computerised Systems

Annex 11 to the EC-GMP Guide titled "Computerised Systems" dates back to the early 1980s and has remained more or less unchanged since then.

The basic content of Annex 11 can certainly be applied to many IT areas still today. However, both inspectors and the industry have more and more difficulties in assessing new technological developments with the help of this regulation.

For this reason, the EMEA suggests establishing an Ad Hoc GMP Services Group whose task it will be to update/revise Annex 11. In addition, Chapter 4 "Documentation" of the EC-GMP Guide is meant to be reviewed at the same time. Whereas up to now, Chapter 4 focussed on "paper documentation", in the future it should also deal in detail with "electronic documentation", not least in view of the revision of Annex 11.

The following schedule is planned for the revision of the two documents:

January 2007: Establishing the Services Group for the draft version
By April 2007: First discussion of the Services Group
September 2007: First discussion of the drafts at the Ad Hoc Group Meeting
December 2007: Handing over the draft to the Commission so that it can be published for commenting by the industry
December 2008: Presenting the final version to the Commission
In the following we have listed some of the questions that should be addressed by the Ad Hoc Group during the revision of Annex 11:
  • How can requirements laid down in PIC/S 011-2 "Good Practices for Computerised Systems in regulated "GxP" Environments" be included?
  • Clarifications on the subjects risk analysis, electronic records and PAT
  • Inclusion of references to Chapter 4 "Documentation"
  • Clarification of the validation requirements (this certainly refers to harmonisation with the GAMP Guide)
  • Inclusion of the principles of ICH Q9 "Quality Risk Management"
  • Highlighting the topic "electronic signatures" against the background of European requirements
  • This Services Group should consist of 3-5 experts from different countries. According to the author of this news, it would not come as a surprise if the members of the Ad Hoc Group were identical with the PIC/S Expert Circle on Computerised Systems, nor would it be a bad thing since the PIC/S document PI 011-2 "Good Practices for Computerised Systems in Regulated "GxP" Environments" represents the regulatory state of the art.

    The following ECA events focus on specific aspects of computerised systems:

    Dr Andreas Mangel
    On behalf of ECA

    The Concept Paper on the revision of Annex 11 and Chapter 4 can be downloaded here - the deadline for comments is 31 March 2007:

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