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On 8 June 2006, the ICH published the Draft Guideline Q4B titled
"Regulatory Acceptance of Analytical Procedures
and/or Acceptance Criteria". This document describes a procedure
meant to facilitate the acceptance of pharmacopoeial methods on the part
of the registration authorities.
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:
http://www.ich.org/LOB/media/MEDIA3092.pdf
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:
http://www.ich.org/LOB/media/MEDIA3093.pdf
Both documents have already been published by EMEA as drafts for
commenting by the industry. Author:
Dr Günter Brendelberger
On behalf of ECA
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