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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.
Bioburden contamination control is a critical aspect of pharmaceutical, medical device and personal. care product manufacturing and one that is a primary focus of cGMP. 1. . This article will attempt to. provide an overview of contamination control from a holistic perspective, discussing this control. system as a process with different aspects of validation, control and monitoring, each contributing. to the final state of control. The process has various aspects to it.