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Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
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.
For more information on change control strategy contact us here or visit the West Knowledge Center to view scientific documents authored by West experts.
From all corners of the globe, our team members banded together to uplift their local communities during our Sixth Annual Global Food Drive. The COVID pandemic has contributed to a severe increase in global food insecurity, due to loss of incomes, disruptions in food supply chains, and other factors resulting from COVID. Our communities are in acute need of our help more than ever.
Binghuan Cao, Sr. Tech Support, Maintenance, China, has worked at West for 12 years. He is a highly motivated, philanthropic activist for West without Borders activities and local community services. Binghuan has been involved in West Without Borders activities in China for the past 10 years. In addition to donating, he has volunteered as a representative for West in support of local schools and community organizations.
Are you challenged with managing change as it relates to a drug substance, drug product or drug/device combination product? You are not alone!
Container closure integrity (CCI) is a fundamental requirement of every sterile drug package. Recently, the United States Pharmacopeia Convention (USP) published a guidance in this area that, among other key topics, addresses test methods in detail: Chapter <1207> Package Integrity Evaluation – Sterile Products. However, proper test method is only one aspect of achieving good CCI.
At West, we often get asked “What extractable compounds are present in your products?”, “What are the current requirements for Extractable and Leachable testing?” and “How do I make sense of all of this data and get the regulatory authorities what they want?”
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