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PDG
PDG Harmonization Policy (PDF)- PDG Working Procedure (PDF)
- PDG Press Release (PDF)
- PDG State of Work (PDF)
- Implementation Timetable ( General Chapters (PDF) | Monographs (PDF) )
- Stage 4 Official Inquiry
ICH-Q4B
- Status of Annexes (PDF)
- Guideline: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Step 4) (PDF)
- Annex 1: Residue on Ignition/Sulphated Ash General Chapter (Step 4) (PDF)
- Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (Step 4) (PDF)
- Annex 3: Test for Particulate Contamination: Sub-visible Particles General Chapter (Step 4) (PDF)
- Annex 4: Microbiological Examination of Non-sterile Products (Step 4)
- Annex 4A: Microbial Enumerations Tests General Chapter (PDF)
- Annex 4B: Test for Specified Micro-organisms General Chapter (PDF)
- Annex 4C: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF)
- Annex 5: Disintegration Test General Chapter (Step 4) (PDF)
- Annex 6: Uniformity of Dosage Units General Chapter (Step 2) (PDF)
- Annex 7: Dissolution Test General Chapter (Step 4) (PDF)
- Annex 8: Sterility Test General Chapter (Step 4) (PDF)
- Annex 9: Tablet Friability General Chapter (Step 4) (PDF)
- Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (Step 4) (PDF)
- Annex 11: Capillary Electrophoresis General Chapter (Step 4) (PDF)
- Annex 12: Analytical Sieving General Chapter (Step 4) (PDF)
- Annex 13: Bulk Density and Tapped Density of Powders General Chapter (Step 4) (PDF)
- Annex 14: Bacterial Endotoxins Test General Chapter (Step 4) (PDF)
- Frequently Asked Questions (PDF)