GMP News No. 817
17 October 2006
New ICH Guideline Q4B
ICH Guideline Q6A on specifications had encouraged the Pharmacopoeial Discussion Group (PDG) to develop harmonised texts. However, up till now there has not been a regulatory implementation of this aim.
It is the objective of this new guideline to facilitate the acceptance and exchangeability of published methods and to reduce the number of redundant tests.
In this context, the term APAC means "Analytical Procedures and/or Acceptance Criteria" and refers to pharmacopoeial monographs, general monographs, analytical procedures and/or related acceptance criteria.
The term RAAPAC stands for "Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria" and includes the 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 every topic for which an APAC was evaluated - according to the standard ICH procedures.
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 Procedures
and/or Acceptance Criteria" was now also issued by ICH in June
2006. It can likewise be accessed:
Both documents have already been published by EMEA as drafts for commenting by the industry.