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Per Dossier Requirements for Pharmaceutical Packaging Materials (Interim), announced by China Federal Drug Administration (CFDA) (CFDA Announcement 2016 #155), a related guideline will be published for pharmaceutical companies’ reference when they encounter any change notifications from materials suppliers. Earlier this year during the Pharmaceutical Packaging Regulation and Technical Open Symposium in China, which was co-organized by West’s Global Scientific Affairs team and CNPPA (China National Pharmaceutical Packaging Association), Fran DeGrazio, Vice President of Scientific Affairs and Technical Services, presented the West change control strategy. The presentation explained the strategy's importance in assuring product quality and consistency, and covered the following points:
Proper change control procedures, coupled with a robust control strategy, are necessary to assure adequate packaging component quality. Tests and specifications should be based on scientific understanding of formulation and product requirements. Fran’s presentation demonstrated that the West change control strategy is based on robust scientific understanding of elastomeric packaging components.