THE 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.
An edition of Sterilization Validation and Routine Operation Handbook
(2001)
Sterilization Validation and Routine Operation Handbook
Radiation
by Anne Booth
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Sterilization Validation and Routine Operation Handbook: Radiation
April 4, 2001, CRC
Hardcover
in English
1587160579 9781587160578
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"THE 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."
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