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Harmonized Microbiology General Chapters

Type of Posting: Interim Revision Announcement: POSTPONEMENT OF HARMONIZATION

Posting Date: 14–Nov–2006

Revised Date: 22–Dec–2006

The implementation of the following USP–NF Microbiology General Chapters scheduled for August 1, 2007, has been postponed until May 1, 2009.

  • <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests (USP 30, page 89)
  • <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms (USP 30, page 93)
  • <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances For Pharmaceutical Use (USP 30, page 585)

The current USP–NF General Chapters <61> Microbial Limit Tests (USP 30, page 83) and <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products (USP 30, page 584) are effective until May 1, 2009.

Implementation of the postponed harmonized General Chapters prior to the May 2009 date is at the discretion of the user and may be subject to regulatory consideration.

Questions should be directed to Dr. Radhakrishna Tirumalai, Senior Scientist (