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In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
The packaging material supplier may propose a storage condition and shelf life based on such studies. However, the design of studies and parameters to be evaluated are still unclear at this stage. Below are the two announcements regarding packaging of parenteral drug products:
Last year, during an open symposium co-organized by West Scientific Affairs and CNPPA (China National Pharmaceutical Packaging Association), an expert from CFDA Jinan Quality Inspection Center for Pharmaceutical Packaging Materials spoke about preparation of a guidance for stability studies. The following points were highlighted:
Stability studies will continue to be a focus in the pharmaceutical packaging industry in China. West Scientific Affairs will maintain vigilance and be ready to act on updates from agencies and industrial associations.
To gain more insight on how West can help you visit our Analytical Labs section of the website or our Knowledge Center.
Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from 30 EEA (European Economic Area) countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the EMA (European Medicines Agency). For a medicinal product to be available on the market it needs to have a marketing authorisation. The marketing authorisation application (MAA) must provide evidence of the efficacy, safety and quality of the medicine. When applying for a marketing authorisation for a medicine, the marketing authorisation application is submitted to a regulatory authority, which will assess the medicinal product’s pharmaceutical and chemical quality, efficacy and safety, as well as its risk-benefit ratio.
Want to learn more about quality planning for injectable delivery systems? Join West’s technical experts on April 24, 2012 at the Renaissance Raleigh North Hills Hotel for a free educational seminar.
West employees have forged a strong bond with many of the local organizations they support through the West without Borders fundraising initiative.
Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.
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