New Good Manufacture Practice for biological products

On May 6, the national medical product administration issued the revised appendix of biological products in the ” Good Manufacture Practice for pharmaceutical products ” (2010 version), which will come into effect as of July 1, 2020. The new appendix strengthens the biosafety management, clarifies the requirements for key personnel of vaccine enterprises, increases the content related to the quality trend analysis of vaccine products, and strengthens the data management in the vaccine production process, as well as the quality management of adjuvants used in vaccine production. Article 59 of the new appendix stipulates that vaccine production shall “record allRead More →

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