THE REGULATORY STANDARDS FOR ASEPTIC PROCESSING ARE UNDER SCRUTINY as industry moves to interpret and implement the 2008 revisions to Annex 1 of the EU GMPs. At recent public forums, the dialogue on the implications of the Annex 1 revisions has brought to the surface deeper questions about the foundation on which aseptic processing standards have rested. Coming to the fore is the tension between prescriptive guidance based on worst-case regulator experience and the advancement of a science and risk-based quality regulatory paradigm more adaptive to technology and harmonization. At issue in the discussions over the clean-room classification/monitoring and vial capping provisions in the revised annex is how a manufacturer’s valuable control resources can be most effectively deployed to analyze and address aseptic processing risks. The limitations of traditional microbial measurements versus the potential of science and engineering to find and eliminate contamination sources is among the big-picture concerns on the table.
VOICES FROM THE DIALOGUE:
• MHRA inspector Hopkins on Annex 1-related inspection issues (Appendix I, pp. 21-24)
• Cleanroom consultant Farquharson on Annex 1 implementation (Appendix II, pp. 25-32)
• USP expert committee chair Akers on improving aseptic monitoring standards (Appendix III, pp. 33-40)
CONTENTS:
2……Annex 1 Revision Took Time
3……Revisions In Focus At Public Forums
6……Classifying/Monitoring Guidance Amended
6……Should 5 Micron Monitoring Be Required?
9……Continuous Monitoring Raises Alarms
9……Monitoring Microbes Has Limits
11….Lid Opened On Vial Capping Debate
14….Guidance vs. Rule
15….Prescriptive Guidance vs. Harmonization
16….From Worst-Case To QRM-based Standards
18….The Problem Of Regulating By Numbers
20….Risk Analysis Tools Draw Risk Assessment
