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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.