Container/Closure Systems
(Chairs) Daniel Malinowski
Container Closure Working Group Update Intro
PQRI Update -June 2011 (Power Point Presentation)
New ASTM Standards—Labels in Anesthesiology and Pharmaceutical Packaging
The Container/Closure Systems WG is developing test methods and evaluation criteria in support of FDA’s PACPAC guidance.
Draft Guidance for Industry Stability Testing of Drug Substances and Drug Products (Draft June 1998)http://www.fda.gov/cder/guidance/1707dft.pdf
Final Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999)http://www.fda.gov/cder/guidance/1714fnl.pdf
Final Guidance for Industry Changes to an Approved NDA and ANDA (November 1999)http://www.fda.gov/cder/guidance/2766fnl.pdf
Meeting Minutes
- February 12, 2013 (PDF)
- January 24, 2012 (PDF)
- July 12, 2011 (PDF)
- June 7, 2011 (PDF)
- April 12, 2011 (PDF)
- March 8, 2011 (PDF)
- February 18, 2011 (PDF)
- November 9, 2010 (PDF)
- August 10, 2010 (PDF)
- April 13, 2010 (PDF)
- February 10, 2009 (PDF)
- November 11, 2008 (PDF)
- September 11, 2008 (PDF)
- September 27, 2006 (PDF)
- June 14, 2005 (PDF)
- May 13, 2005 (PDF)
- January 27, 2004 (PDF)
- December 6, 2001 (PDF)
Additional Material of the Container/Closure Systems Working Group