(1998; 18 pages)
Container and closure testing in lieu of sterility testing - draft guidance available
United States of America. The Food and Drug Administration has announced the availability of a draft guidance document entitled "Guidance for Industry: Container and Closure Integrity Testing in lieu of Sterility Testing as a component of the Stability Protocol for Sterile Products", which is intended to provide recommendations and offer alternative methods for sterility testing to confirm the integrity of container and closure systems for sterile biological products, human and veterinary drugs, and medical devices. The draft guidance applies only to the replacement of the sterility test with an appropriate container and closure integrity test in the stability protocol, and is not offered as a replacement for sterility testing for product release.
Copies of the guidance may be obtained from the Dockets Management Branch (HFA-305), Food and Drug Administration, 1401 Rockville Pike, Rockville MD 20852-1448, USA (with one self-addressed adhesive label) or from the Internet at: http://www.fda.gov/cber/guidelines.htm.
Reference: Federal Register 63(18): 4272-3 (1998).