Lynn Yao

Senior Specialist, SA, CN

January 19, 2018

West Expert Addresses Extractables and Leachables at Symposium in China

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.

Diane Paskiet presenting at China Symposium

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.