ABSTRACT
T HE basic requirement for validating manufacturing processes, of which sterilization is one, is defined in the Food and Drug Administration's Quality System Regulation 21 CFR Part 820, Sec. 820.75, "Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a,high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented."
