EMEA publishes Drafts regarding the ICH Topic Q4B

Within the <Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions> the Q4B Expert Working Group of the EMEA published the drafts of the new Annex 4A, 4B and 4C in June. They deal with the topics of the microbiological examination of non-sterile products:

  • Annex 4A with the "Microbial Enumeration Test",
  • Annex 4B with "Tests for specified Microorganisms" and
  • Annex 4C with the "Acceptance Criteria for pharmaceutical Preparations and Substances for pharmaceutical Use"

The Expert Working Group reviewed the texts of EP, USP and JP and considers them interchangeably applicable in the ICH regions. They would build the written base for a formal simplification for the pharmaceutical manufacturer in the harmonisation process and will avoid redundancies in tests by the pharmaceutical industry. Only in the FDA's consideration one can find the exception that in special cases the manufacturer must demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method.  But the question is how often this special case will happen in daily practice.

Further information you will find here:

Axel H Schroeder
On behalf of the European Compliance Academy (ECA)


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