This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.

The ICH Harmonised Annex was finalised under Step 4 in November 2008. This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for …

Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation...

In November 2003, ICH established the Q4B EWG to evaluate and recommend pharmacopoeial texts that are proposed for use in the three ICH regions. The Q4B EWG anticipates that the PDG will be the principal source of pharmacopoeial text proposals.

In November 2003, ICH had established the Q4B EWG to evaluate and recommend pharmacopoeial texts to be proposed for interchangeable use in the three founding ICH regions (USA, European Union, Japan).

Apr 13, 2020 · This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory...

Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation...

This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). 2. Q4B OUTCOME 2.1 Analytical Procedures The ICH Steering Committee, based on the evaluation by the Q4B Expert Working

Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

This document describes a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial analytical procedures and/or acceptance criteria.