FDA Posts ICH Q4B Analytical Guidances

Aug 10, 2006

The US Food and Drug Administration (Rockville, MD, www.fda.gov) has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC), available online at http://www.fda.gov/cder/guidance/7386dft.htm. The guidance describes the  International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, www.ich.org) Q4B draft standard (as revised in June), outlining the procedure for "acceptance by regulatory authorities of pharmacopoeial" standards for APAC (analytical procedures and/or acceptance criteria).  (ICH's  Q4 activities focus on harmonizing the requirements of the world's pharmacopoeias.)

At the same time, FDA published the first specific draft guidance under the RAAPAC procedure, Annex 1:  Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC) (http://www.fda.gov/cder/guidance/7387dft.htm).

The guidance describes the reconciliation (via specification of sample size and a caveat on test-furnace calibration) of US Pharmacopeia, European Pharmacopoeia, and Japanese Pharmacopoeia testing procedures for residual ash, an index of the inorganic impurities in an organic sample.

The eight-page guidance and four-page annex were posted jointly by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.