Creating And Manufacturing Drugs Including Biologics: Revision history

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20 April 2024

  • curprev 00:0900:09, 20 April 2024SamShockley7663 talk contribs 3,067 bytes +3,067 Created page with "<br>Manufacturers and product sponsors are topic to FDA laws and rules. Current good manufacturing follow (CGMP) rules define the minimal high quality requirements for manufacturing of drugs, including biologics, and are established to make sure that merchandise are secure and efficient for human use. See CGMP regulations for drugs and chemistry, manufacturing and controls (CMC) and CGMP guidances for biologics. Relevant regulations governing high quality can be present..."