Opportunity to Comment: Concept Paper on the revision of Annex 11- GMP Computerised Systems

ISPE plans to comment onthe EMA proposed guidance document, Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products - Computerised Systems and welcomes input from ISPE Members.

The proposed guideline will replace: - Eudralex Volume 4: Annex 11 Computerised Systems - for PIC/S participating authorities: PE 009-15: Annex 11 - 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 version was issued in 2011 and did not give sufficient guidance within a number of areas. Since then, there has been extensive progress in the use of new technologies."

Steps to Commenting:

Please Note: All comments received will be vetted by a task team of subject matter experts and by the Regulatory Quality Harmonization Committee (RQHC). Please be aware that any comments accepted for inclusion may be edited for clarity and/or combined with other words on behalf of ISPE. Comments will be anonymized before submission.

• Please review the proposed guidance: Concept Paper on the revision of EU GMP Annex 11 (europa.eu)