ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCHMP/ICH/308867/08
Published01/12/2008
Effective from01/06/2009
KeywordsMicrobiological, non-sterile, microbial attributes, pharmacopoeia
DescriptionThis annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbiological examination of non-sterile products by regulatory authorities in the ICH regions.


Document history

First version

Current version

Adopted guideline


Draft guideline

In operation: 01/06/2009–present


Published: 01/06/2008


Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more