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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 Challenges of E&L Study Under Changing Regulatory Environment at the second-annual Extractables and Leachables China, 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.
She shared West’s up-to-date knowledge on regulatory requirements and West’s comprehensive experience regarding E&L, specifically on four aspects of elemental impurities:
It was emphasized that to address these aspects careful monitoring and understanding of the regulatory requirements is needed first. Second, a risk-based approach with a holistic understanding of potential sources of elemental impurities regarding, in particular, components and systems is needed.
Selection of the right components is critical. Through Technical Customer Support (TCS) and the Integrated Solutions program, West can not only advise on proper selection, but design and execute the studies needed to support regulatory compliance. For more, contact a TCS representative or Account Manager.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.