Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile Devices
The purpose of these instructions is to assist FDA field personnel in applying the device GMP regulation to inspections of manufacturers of sterile devices. File these instructions with CP7378.830 "Inspection of Medical Device Manufacturers" (10-24-83) for reference when conducting GMP inspections of sterile device manufacturers. The examples given concern conditions, procedures and methods that can directly affect sterility specifications. The examples are not intended to cover all possible variations in sterilization practices, and may not apply in all situations. They are general factors for the use in determining whether a manufacturer's production procedures and sterilization processes are in compliance with the GMP regulation.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.