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As members of the pharmaceutical community, we’re often keenly aware of regional regulatory differences. But it’s just as useful to focus on points of harmony, whether these are well-established, emerging, or implicit in regulatory and industry feedback.
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)
2 ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System
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
Packaging components are an integral part of a drug product. Selecting the right packaging system is not trivial--it can impact patients' health, operational efficiency, drug compatibility and drug stability. A good container closure system includes a glass or polymer vial, an elastomer stopper and an aluminum seal.
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
In recent years, regulatory guidelines such as The European Medicines Agency (EMA) Annex 1 “Manufacture of Sterile Medicinal Products” have influenced the requirements for the seal crimping processes. EMA Annex 1 specifies that the manufacturing of sterile products is subject to “special requirements in order to minimize risks of microbiological contamination.” The EMA refers to two processes in fill-finish area of manufacturing plants performing aseptic filling: Aseptic Crimping and Clean Crimping. To ensure compliance, pharmaceutical manufacturers need to select the proper seal for each process.
Overview of EU GMP Annex 1<br />EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.<sup>1</sup> It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.<br />In August 2022, the final draft of EU GMP Annex 1 was released after years of development and took effect on 25 August 2023. In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
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