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In its current form, Annex 1 (Manufacture of Sterile Products) of the EudraLex Volume 4 Good Manufacturing Practice Guidelines has elicited its fair share of praise as “the most robust and specific guidance that we have,”¹ as well as puzzlement due to ambiguities around changing technologies and the ICH Q9 and ICH Q19 guidelines² that followed its 2008 publication. What is clear, is that Annex 1 has become an international reference standard, and that few informed discussions on clean capping requirements take place without some awareness of its provisions.
Both Annex 1 and FDA guidelines³ can be met by focusing on practical considerations such as air supply, design, process elements, and ‘clean’ process verification (Michael Baumstein, Pfizer, ISPE Tampa Conference 20104). Such approaches tend to highlight the common ground between regulatory authorities when it comes to implementation. A shared philosophy further manifests itself in regulatory feedback. While the FDA guidance, unlike Annex 1, does not spell out the need for lot to lot bio-burden control, FDA inspectors were very clear in a 2011 warning to a major manufacturer on the need to establish such controls for capping operations5. In this context, it is not surprising that West customers are asking for help in ensuring that they go beyond a narrow interpretation of local regulatory guidelines on capping. West’s Flip-Off™ Plus seals, which introduce bio-burden control at lot level, are a response to these questions and industry concerns.
FDA and EMA written guidelines may never be fully harmonized in terms of their scope and specificity. There are valid, long-standing cultural reasons for this: given the national and linguistic diversity of its stakeholders, the EMA is under more pressure to provide detailed, written frameworks. But the absence of such detail from North American guidance should not be taken to indicate divergence. Ultimately, navigating the challenges of operating successfully in an increasingly international environment comes back to the need to think in terms of overall quality and risk management rather than limited compliance goals. As Annex 1 continues to evolve through regulatory and industry consultation, contact your West representative to explore how our Flip-Off™ Plus seal offerings can meet your current and future capping needs.
1 West Pharmaceutical North America customer, March 18 (Working Group, 2015 PDA Annual Meeting, Las Vegas)
4 An Implementation Example of a Clean Process for Vial Capping, presented by M. Baumstein at the International Society for Pharmaceutical Engineering (ISPE) Tampa Conference, 22-25 Feburary, 2010, Tampa, Florida, USA