ECA Foundation submits comprehensive comments on Annex 1 Revision to EU Commission

The ECA Foundation has set up a Task Force to comment on the proposed revision to Annex 1 to the EU GMP Guide on the Manufacture of Sterile Medicinal Products. Members of this Task Force were: Dr Friedrich Haefele, Boehringer Ingelheim (Germany); Alexandra Staerk, Novartis Basle (Switzerland); Dr Tilmann Rock, Roche Mannheim (Germany); Dr Ingrid Walther, Independent Expert (Germany); Arjan Langen, MSD (The Netherlands); Stephan Loew, CSL Marburg (Germany); Walid El Azab, Steris (Belgium); Dr Jean-Denis Mallet, NNE Pharmaplan (France); Dr Bernd Renger, Independent Expert (Germany).

The EU GMP Guide Annex 1 will have a major impact on industry. This is why the Task Force has put a lot of efforts to comment on the new proposed requirements.

The ECA Foundation Task Force reviewed the draft Annex 1 and provided the attached comments for your consideration. These comments were not targeting at lowering the requirements. However, the Task Force believes that some areas require further clarification, the main areas for concern include:

  • To avoid misinterpretation, misunderstanding and uncertainty, there is need for clarification and definition for “disinfection, sterilisation, decontamination, sanitisation, bio-decontamination.” ECA strongly request that these terms receive an unequivocal definition, which should be used throughout the document. More details are provided in the attached comments’ document.
  • Although the document focuses on the application of the Quality Risk Management principles, which is highly appreciated by the ECA members, some sections contain specific and detailed requirements, that may not be scientifically sound nor applicable for some manufacturing processes. Setting forth a large number of specific and detailed requirements does not fully comply with the principles of the QRM-concept, where manufacturers should define and adhere to measures and actions, which need to be adequate for the individual process and commensurate with specific process risks.
  • Adaptation of the firmly specified requirements in order to allow more flexibility and provide the chance for adherence to the requirements under consideration of the specific process properties would be advantageous. This will also avoid unnecessary and additional burden in routine operations, without compromising product quality and patient safety in any way.

For more information please see the ECA Foundation’s detailed EU GMP Annex 1 comment which was sent to the EU Commission.