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Revision Bulletin
NOTICE OF POSTPONEMENT

Harmonized Microbiology General Chapters


November 14, 2006
Revised December 22, 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 ().

What's New

Changes to the Dissolution Performance Verification Test (11/20/09)

PF 35(6) Errata (10/30/09)

New official Text for October: 15 Revisions Bulletins (10/30/09)

Pending Standards for the month of October (10/30/09)

PF 35(6), November-December 2009: Highlights and Stimuli Articles (10/23/09)

Admission Criteria and Safety Classification for Dietary Supplements Guideline (10/22/09)

Elemental Impurities Hot Topics information updated (10/13/09)

General Chapter <1151> Pharmaceutical Dosage Forms (10/06/09)

Heparin Hot Topics information updated (10/02/09)

PF Redesign

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