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It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.
Extractables and leachables (E&L) remain as one of the hottest topics in China – a topic to which West makes a strong commitment – in order to anticipate and address ever-changing regulatory and technical requirements. As part of this commitment, Lynn Yao, Scientific Affairs Manager at West, presented <em>Challenges of E&L Study Under Changing Regulatory Environment</em> at the second-annual <span style="text-decoration: underline;">Extractables and Leachables China</span>, hosted by Smithers Rapra, September 2019 in Shanghai. This event assembled local stakeholders and experts for two days of presentations, training, and discussion on the China regulatory landscape, testing methods, and technical advances.
In <a href="/pt-pt/blog/2017/june/packaging-supplier-regulatory-support-part-2">Part 2</a> of this series, we discussed the importance of choosing a packaging component supplier with a global focus. In this post, we’ll address the need for a supplier to understand and align with your drivers.
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