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To develop a guide of best practices for establishing appropriate controls on nonsterile manufacturing environments for pharmaceutical manufacturers, the Kansai Study Group of the Parenteral Drug Association Japan Chapter explored relevant issues in-depth and published the results of their study, ″Manufacturing Environmental Control for Non-sterile Drug Products″ in the PDA Journal of GMP and Validation in Japan (1). This review summarizes the background of that study and the structure of the published article and, to help readers make the most
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