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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.
Ophthalmic drug products (ODPs) present a special challenge for the measurement of extractables and leachables (E&L) due to the presence of multiple leachables sources. ODPs typically are packaged in labelled, semipermeable polymer (e.g., low density polyethylene) containers (i.e., primary container) and stored in cardboard containers (i.e., secondary container) along with instructions for use. The polymer, label, cardboard and paper are all possible sources of leachables.
West hosted a dedication ceremony on September 17 to mark the start-up of its recently completed compression molding plant in the Shanghai Zhangjiang High-Tech Industrial Development Zone Qingpu Park in China. The new plant is adjacent to West’s injection molding facility.
How does West respond to increased demand to produce supplies needed for use with treatments to combat the coronavirus? The answer is – with years of experience, careful planning, and a robust manufacturing program. We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe, effective COVID-19 vaccine, which includes expanding labor and equipment resources.
The pharmaceutical and biotech industry continues to deal with ongoing challenges especially in respect of strengthening their research and development (R&D) productivity and innovation model.
It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted.<span> </span>This comprises knowing of proposed changes as soon as announced, and being well prepared to accommodate them.<span> </span>Expected to be implemented by late 2018 – the functionality tests section of USP Chapter <381> (<em>Elastomeric Closure for Injections</em>) will be removed, and greatly expanded functionality tests will be incorporated in new USP Chapter <382> (projected title: <em>Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems</em>).<span> </span><p> </p>
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