ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).
The US Food and Drug Administration (Rockville, MD, www.fda.gov) has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC), available online at http://www.fda.gov/cder/guidance/7386dft.htm.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At the same time, FDA published the first specific draft guidance under the RAAPAC procedure, Annex 1: Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.