Recognition of Compendial Methods - EMEA Publishes New ICH Q4B Documents

GMP News
16 January 2008
 

Recognition of Compendial Methods -
EMEA Publishes New ICH Q4B Documents

 
In December 2007, EMEA published the document <Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions>. This document is meant to come into force in June 2008.

The objective is that a working group (Q4B Expert Working Group) assesses individual pharmacopoeial texts and gives recommendations in order to facilitate the recognition of compendial methods in the three ICH regions. For this purpose, it is necessary to publish additional topic-related annexes. These Q4B activities aim at creating a situation where the pharmaceutical industry does not have to perform tests several times over.

These efforts are needed in order to achieve a harmonisation of the test methods
mentioned in the two ICH documents on specifications (Q6A and Q6B). Only then will the two ICH guidelines Q6A and Q6B really be complete!

For a concrete, method-specific implementation, the following three annexes have been published:

1. Annex 1 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter:

http://www.emea.europa.eu/pdfs/human/ich/22206306en.pdf

2. Annex 2 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter (draft published for commenting until June 2008):

http://www.emea.europa.eu/pdfs/human/ich/55940907en.pdf

3. Annex 3 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter (also a draft version to be commented by June 2008):

http://www.emea.europa.eu/pdfs/human/ich/56117607en.pdf

The complete document "Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" can be found on the Internet at the address http://www.emea.europa.eu/pdfs/human/ich/22200706en.pdf
  

The testing methods of the pharmacopoeias, especially those of USP and Ph.Eur., are among the focus topics of the ECA education course "Quality Control of Raw Materials" taking place in Copenhagen on 11-12 June 2008.


Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)
 

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