Research Catalog

Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

Title
Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.
Publication
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008]

Available Online

https://purl.fdlp.gov/GPO/LPS111964

Details

Additional Authors
  • Center for Biologics Evaluation and Research (U.S.)
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Devices and Radiological Health (U.S.)
  • Center for Veterinary Medicine (U.S.)
Description
i, 6 pages : digital, PDF file
Alternative Title
Container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
Subject
  • Containers > Testing
  • Caps and closures > United States > Testing
  • Biologicals > United States
  • Drugs > United States
  • Medical instruments and apparatus > United States
Note
  • Title from PDF title page (viewed on Apr. 28, 2009).
  • "February 2008."
System Details (note)
  • Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://www.fda.gov/cber/gdlns/contain.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4802:C 76
OCLC
marcive319539400
Title
Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.
Publisher
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
System Details
Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://www.fda.gov/cber/gdlns/contain.pdf ; current access is available via PURL.
Connect to:
https://purl.fdlp.gov/GPO/LPS111964
Added Author
Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
Center for Devices and Radiological Health (U.S.)
Center for Veterinary Medicine (U.S.)
Gpo Item No.
0499-T-02 (online)
Sudoc No.
HE 20.4802:C 76
View in Legacy Catalog