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1 December 2022

Public consultation on concept Paper on the revision of Annex 11 of the EU GMP – Computerised Systems


The European Medicines Agency has published for public consultation a concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems.


This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP) guide. Annex 11 is common to the member states of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The current Annex 11 does not give sufficient guidance within a number of areas already covered, and other areas, which are becoming increasingly important to GMP, are not covered at all. The revised text will expand the guidance given in the document and embrace the application of new technologies which have gained momentum since the release of the existing version. If possible, the revised document will include guidelines for acceptance of Artificial Intelligence / Machine Learning (AI/ML) algorithms used in critical GMP applications. This is an area where regulatory guidance is highly needed as this is not covered by any existing regulatory guidance in the pharmaceutical industry and as pharma companies are already implementing such algorithms.


The updated Annex 11 is intended to benefit both industry and regulators by clarifying expectations to areas already covered, by broadening these to areas not yet covered, and by pushing the adoption of a common approach between EU and non-EU regulatory authorities. Revision of Annex 11 will facilitate a better understanding of expectations for the use of computerised systems within the manufacturing of medicinal products, and thereby, enhance the quality and safety of products and the integrity of data. No unnecessary adverse impact on the industry with respect to either resources or costs is foreseen, although there is always a cost associated with being in compliance (or quality). The revision may require some systems and processes to be modified over a period of time.


Comments should be provided using this template and sent to by 16th of January 2023.