FDA Posts ICH Annex Quality Guides for Drug Makers
FDA has posted 10 annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The documents describe the evaluations and recommendations by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. The Q4B annexes can be downloaded by clicking on each link below:
- Q4B: Annex I: Residue on Ignition/Sulphated Ash General Chapter (PDF - 58KB)
- Q4B: Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 69KB)
- Q4B: Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 993KB)
- Q4B: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 69KB)
- Q4B: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 69KB)
- Q4B: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 57KB)
- Q4B: Annex 5: Disintegration Test General Chapter (PDF - 69KB)
- Q4B: Annex 8: Sterility Test General Chapter (PDF - 68KB)
- Q4B: Annex 9: Tablet Friability General Chapter (PDF - 68KB)
- Q4B: Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 57KB)