<71> Sterility Test

Expert Committee: Microbiology and Sterility Assurance

Coordinating Pharmacopeia: EP

A harmonized standard for Sterility Test has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Since there was no web posting at the time of sign-off of this chapter, all previous PDG sign-offs and Stage 6 postings are summarized as below:

• Download the Sterility Test PDG Sign-Off Cover Pages:
  • 10-Jun-2009 Rev.1 Cor.3
  • 11-Nov-2008 Rev.1 Cor. 2
  • 03-Jun-2008 Rev.1 Cor. 1
  • 30-Oct-2007 Rev.1
  • 10-Sep-2002
• Previous Stage 6 posting in PF 34 (6), 2008 (IRA)
• Previous Stage 6 posting in PF 29 (4), 2003 (IRA)

Should you have any questions about this General Chapter, please contact Rahdakrishna Tirumalai (301-816-8339 or rst@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).