Sterilization Validation and Routine Operation Handbook
Subtitle: Radiation
Publisher: CRC
Published: April 4, 2001
Language: eng
Format: Hardcover
Number of pages: 168
ISBN-13: 9781587160578
Subjects: Technology; Science; Material Science; Radiation
First sentence: 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.