The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

Origin/Publisher:

FDA

Document Type:
Guidance for Industry
Content:
This guidance document provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.

Go back

GMP Conferences by Topics