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Defining your GMP training program with a training procedure

FDA and quality auditors expect pharmaceutical manufacturing companies to have standard operating procedures (SOPs) defining their GMP training programs, but it is up to each company to determine what should be included its SOP. More are information sources to consider and specific topics to include when writing a training program SOP.

Having a standard operating procedure (SOP) that defines your training program is not a specific requirement of the drug CGMP regulations (21 CFR 211.25). However, a training SOP is an expectation of the agency and quality auditors because it is both feasible and valuable: The leading companies in our industry each have one, and it adds to the control of ...

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