Q1F-WHO稳定性指导原则 无中文版.pdf

© World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and fi nished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles 2. Guidelines 2.1 Active pharmaceutical ingredient ………………… 2.1.1 General 2.1.2 Stress testing 2.1.3 Selection of batches 2.1.4 Container closure system 2.1.5 Specifi cation 2.1.6 Testing frequency 2.1.7 Storage conditions …… 2.1.8 Stability commitment 2.1.9 Evaluation 2.1.10 Statements and labelling 2.1.11 Ongoing stability studies 2.2 Finished pharmaceutical product 2.2.1 General 2.2.2 Selection of batches 2.2.3 Container closure system 2.2.4 Specifi cation 2.2.5 Testing frequency 2.2.6 Storage conditions 2.2.7 Stability commitment 2.2.8 Evaluation 2.2.9 Statements and labelling 2.2.10 In-use stability 2.2.11 Variations 2.2.12 Ongoing stability studies 3. Glossary References Appendix 1 Long-term stability testing conditions as identifi ed by WHO Member States. Appendix 2 Examples of testing parameters… Appendix 3 Recommended labelling statements… 87 1. Introduction 1.1 Objectives of these guidelines These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and fi nished pharmaceutical products (F