ABSTRACT
Requirements vs. Expectations The cGMP regulations issued by the U.S. FDA (i.e., the C urrent Good M anufacturing Practice Regulations) in clude, literally, more than what is found in the Code of Federal Regulations (i.e., 21 CFR). What is written in Parts 210 and 211 for the drug industry and Part 820 for the medical device industry are the minimum requirements. Industry practice, FDA concerns (as published for its in vestigators and industry as “Guidance” documents), new technology, etc. can raise the expectations tha t inspec tors have as they examine an operation.
