The New GMP Annex 11 and Chapter 4 is Europe's Answer to Part 11

As mentioned in the GMP Newsletter from 19 January 2011, this month saw the publication of the new revision of European Union (EU) GMP Annex 11 on Computerised Systems and Chapter 4 on Documentation. The impact of these new revisions is extensive as combined they are the equivalent to the FDA's Part 11 regulation for electronic records and signatures. This will be a high level look at both new regulations but for full details please read the full versions of each.

Annex 11 Changes

Increased Scope of Annex 11
The first section to discuss is the Principle that covers the scope and application of the new regulation. The key elements of the Principle are:

  • Annex 11 applies to all forms of computerised systems used as part of a GMP regulated activities.
    This is a wide scope statement and includes all computerised systems including the in-house developed spreadsheets and databases.
  • The application should be validated; IT infrastructure should be qualified.
    This is the major item: the ten words that mean so much validate applications and qualify infrastructure. For the first time in any regulation there is a specific requirement for IT infrastructure qualification.
  • When a computerised system replaces a manual process there should be no resultant decrease in product quality, process control or quality assurance.
    In a carry over from the current version of Annex 11 there is the additional requirement of process control. In essence, it mandates the minimum the quality of a computerised system should be as good as the manual system it replaces but in reality, the computerised system should be much better as the human factor is usually taken out of the process.

In addition to the Annex' increased scope the revisions also affect the areas

  • Risk Management throughout the System Life Cycle
  • New Roles and Responsibilities
  • Suppliers and Service Providers
  • Validation
  • Controls for Ensuring Data Integrity
  • Electronic Signatures
  • IT Support of Validated Systems and
  • Maintaining Validation

For a more detailed analysis of these areas please see the PDF with the full analysis.

Chapter 4 - Documentation
The new version of Chapter 4 ("Documentation") of the EU Guideline to GMP was also published at the same time as Annex 11 and will also become effective on 30 June 2011. The clue to its impact comes in the reason for change of the sections on generation and control of documentation and retention of documents sections "in light of the increasing use of electronic documents within the GMP environment". Furthermore in the principle section it states that "Documentation may exist in a variety of forms, including paper based, electronic or photographic media". This is close to the definition of electronic record in 21 CFR 11 except in Europe for electronic record read documentation.

The European regulators have defined the expected GMP document types in far more detail than their US counterparts, thus making it far easier to understand and implement the new regulation in practice.

Several records and the sections

  • Generation and Control of Documents as well as
  • Retention of Documents

are of particular interest.

To read more about these changes please also see the PDF with the full analysis.

Pharmaceutical Consulting Alliance (

PS: These new developments will be presented and discussed at ECA's Education Course "New EU GMP Annex 11 Regulations for Computerised Systems" in Heidelberg, Germany, on 5-6 May 2011.  Speakers are Dr. Bob McDowall, UK, and Karl-Heinz Menges, European GMP Inspector, Germany.

Conference Recommendations

Go back

GMP Conferences by Topics