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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.
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