Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed

With Step 5, the harmonisation regarding pharmacopoeial texts for use in the ICH regions on tests for specified micro-organisms has been completed. The ICH has been working on the harmonisation of the requirements of the Pharmaocopoeias in the regions of the EU, the U.S. and Japan for several years already. Based on the evaluation by the Q4B Expert Working Group (EWG), the ICH Steering Committee has stated that the official pharmacopoeial texts,

  • Ph.Eur. 2.6.13. Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms,
  • JP 4.05 Microbiological Examination of Non-Sterile Products: II. Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms, and
  • USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

can be used as interchangeable in the ICH regions.

As always with ICH harmonisation processes, there is an addition stating that the FDA may request a demonstration that the chosen method is acceptable and suitable for a specific material or product, irrespective of its origin. The European Union states: "For the European Union, the monographs of the Ph. Eur. have mandatory applicability. Regulatory authorities can accept the reference in a marketing authorisation application, renewal or variation application citing the use of the corresponding text from another pharmacopoeia as referenced in Section 2.1, in accordance with the conditions set out in this annex, as fulfilling the requirements for compliance with the Ph. Eur. Chapter 2.6.13. on the basis of the declaration of interchangeability made above."

For more details please see the complete document "ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms".

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