Harmonisation of the pharmacopoeial Texts for use in the ICH Regions on Micro Enumeration finalized

The harmonisation of the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration has also been completed with step 5. The International Council for Harmonisation (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 recommended that the official pharmacopoeial texts on Microbial Enumeration,

  • Ph.Eur. 2.6.12. Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests,
  • JP 4.05 Microbiological Examination of Non-Sterile Products: I. Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests, and
  • USP <61> Microbiological Examination of Nonsterile Products

can be used interchangeably 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 2.6.12. on the basis of the declaration of interchangeability made above.."

For more details please see the complete document "ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration"

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