Sr. Specialist, TCS, China
十二月 27, 2019
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:
- Generics consistency evaluation requirements in China;
- Relevant elemental impurities requirements;
- Elemental impurities leached from container closure systems;
- Extractable elements study on elastomeric component.
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.