PDG and ICH-Q4B
 PDG |
 PDG Harmonization Policy |
| PDG Working Procedure |
| PDG Press Release |
| PDG State of Work |
| Implementation Timetable ( General Tests | Excipients ) |
| ICH-Q4B |
| Guideline: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Step4) |
| ・ Annex 1: Residue on Ignition/Sulphated Ash General Chapter (Step4) |
| ・ Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (Step4) |
| ・ Annex 3: Test for Particulate Contamination: Sub-visible Particles General Chapter (Step4) |
| ・ Annex 4: Microbiological Examination of Non-sterile Products (Step4) |
| ・ Annex 5: Disintegration Test General Chapter (Step3) |
| ・ Annex 6: Uniformity of Dosage Units General Chapter (Step3) |
| ・ Annex 7: Dissolution Test General Chapter (Step3) |
| ・ Annex 8: Sterility Test General Chapter (Step3) |