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FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. 27 Until final regulations are promulgated, this guidance describes FDAâs expectations regarding. 28 outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 during this. 29 interim period.2 register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and. 23 Cosmetic Act (FD&C Act). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be. 24 adulterated if it is not produced in accordance with CGMP.
The CGMA exam is a computerized case study examination that tests your readiness to apply management accounting knowledge in real-world business situations. Drive best business practices with scenario-planning tools, decision trees, an enterprise risk management assessment tool, and real-world case studies.