Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the Center for Drug Evaluation under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures. The compatibility study discussed therein focused on E&L.
As a world leader in pharmaceutical packaging, West has a rich history and deep understanding of this subject. Last year, in the Pharmaceutical Packaging Regulation and Technical Open Symposium, which was co-organized by West Scientific Affairs and CNPPA (China National Pharmaceutical Packaging Association), Diane Paskiet, Director of Scientific Affairs, shared insights on E&L, as well as suggestions for the China technical guideline.
Diane discussed:
- industry E&L best practices in developed markets
- updates on related USP chapters
- understanding Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures
- CFDA's extractable requirements for bundling review
- responsibilities of packaging suppliers and pharmaceutical companies
- Product Quality Research Institute (PQRI) safety thresholds
At West, patient safety is the highest priority. For more information on E&L, and how West can design and execute studies to evaluate E&L issues to promote patient safety visit the website, our Knowledge Center, or contact a Technical Customer Support representative.
West Pharmaceutical Services Inc. published this content on 19 January 2018 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 19 January 2018 16:09:08 UTC.
Original documenthttps://www.westpharma.com/en/blog/2018/January/west-expert-addresses-extractables-and-leachables-at-symposium-in-china
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