New EU GMP Guide Annex 11 "Computerised Systems"

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for applying GMP for IT systems. For many years the annex remained unchanged and did partly not reflect new IT developments. In 2008 an expert committee wrote a very detailed and comprehensive draft for an amended version which was introduced to the public (see GMP news from 16 April 2008). The draft partly described specific aspects in great detail and was the reason for quite controversial discussions and comments in the pharmaceutical IT world.

These comments were adopted and included in the new "slim" version which was published on 3 January 2011. Together with the new Annex 11 version the EU GMP Guide Chapter 4 "Documentation" was also revised and published.

The new version has to become effective on 30 June 2011.

The Annex 11 content is structured in the five areas "Principles", "General", "Project Phase", "Operational Phase" and "Glossary" with altogether 17 sub-chapters. These sub-chapters are basically the same as in the draft from 2008, partly reworded and in a new order.

Principles

General
1. Risk Management
2. Personnel
3. Suppliers and Service Providers

Project Phase
4. Validation

Operational Phase
5. Data
6. Accuracy Checks
7. Data Storage
8. Printouts
9. Audit Trails
10. Change and Configuration Management
11. Periodic evaluation
12. Security
13. Incident Management
14. Electronic Signature
15. Batch Release
16. Business Continuity
17. Archiving

Glossary

Evaluation:

Compared to the draft from 2008 it is good that the Annex 11 expresses the regulatory goals again instead of regulating detail aspects. This leaves affected companies enough room for interpretation and also provides the chance to cover new technological developments for many years. Those affected can read the details for implementation either in industry guides like the GAMP®5 respectively supplementary GAMP Good Practice Guides or the PIC/S document PI 011-3. The PIC/S (Pharmaceutical Inspection Cooperation Scheme) document addresses inspectors, but everybody can access it. It also is a good basis for preparing an inspection.
 
Further Annex 11 details and its implementation will be discussed during the following events:
Computer Validation in Barcelona, Spain, from 13-15 April 2011
Computer Systems Validation Masterclass in Barcelona, Spain, from 11-13 May 2011

Author:
Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

Literature:
New EU GMP Guide Annex 11 "computerised Systems"
New EU GMP Guide Chapter 4 "Documentation"
PIC/S PI 011-3