Welcome to visit China National Pharmaceutical Packaging Association official website!
  • Return
  • Guidance of Equivalence/Replaceability Assessment and Compatibility Studies for Postapproval Changes to Pharmaceutical Packages

    CNPPA 2022/02/17 13:30:00

    Packaging materials and containers are parts of drug products. Changes in packaging materials and containers may affect the physical and chemical attributes, impurity profiles, content, and stability of the drug products. The risk depends on the route of administration of the drug product, the performance of the packaging materials and containers, and the interactions between packaging and the drug product. In general, changing the pharmaceutical packaging materials and containers should have a beneficial effect on and must not adversely affect the quality of the drug product.

    Attachment:Guidance of Equivalence/Replaceability Assessment and Compatibility Studies for Postapproval Changes to Pharmaceutical Packages(T/CNPPA 3019-2022)

    大乐透最近300期图,福彩3D组选综合走势图新浪彩票,今晚3d会开什么号码,快乐8基本走势图图表新浪爱彩