New ICH Guideline Q4B

GMP News No. 817

GMP News
17 October 2006

New ICH Guideline Q4B

On 8 June 2006, the ICH published the Draft Guideline Q4B titled"Regulatory Acceptance of Analytical Proceduresand/or Acceptance Criteria". This document describes a proceduremeant to facilitate the acceptance of pharmacopoeial methods on the partof the registration authorities.

ICH Guideline Q6A on specifications had encouraged the PharmacopoeialDiscussion Group (PDG) to develop harmonised texts. However, up till nowthere has not been a regulatory implementation of this aim.

It is the objective of this new guideline to facilitate the acceptanceand exchangeability of published methods and to reduce the number ofredundant tests.

In this context, the term APAC means "Analytical Proceduresand/or Acceptance Criteria" and refers to pharmacopoeialmonographs, general monographs, analytical procedures and/or relatedacceptance criteria.

The term RAAPAC stands for "Regulatory Acceptance ofAnalytical Procedures and/or Acceptance Criteria" and includesthe acceptance of analytical procedures - evaluated on the basis of Q4B -by the registration authorities in the ICH regions.

It is intended to publish an annex to the ICH Guideline Q4B for everytopic for which an APAC was evaluated - according to the standard ICHprocedures.

The complete ICH document can be downloaded from the Internet:

A first topic-related annex titled "Q4B Annex I:Residue on Ignition /Sulphated Ash General Chapter Analytical Proceduresand/or Acceptance Criteria" was now also issued by ICH in June2006. It can likewise be accessed:

Both documents have already been published by EMEA as drafts forcommenting by the industry.

Dr Günter Brendelberger
On behalf of ECA

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