WHO 第992号技术报告 附录3 非无菌工艺验证.docxVIP

WHO 第992号技术报告 附录3 非无菌工艺验证 ? Annex 3 Guidelines on good manufacturing practices: validation, Appendix 7: non?sterile process validation Background The appendices of the Supplementary guidelines on good manufacturing practices:validation currently comprise the following: Appendix 1. Validation of heating, ventilation and air-conditioning systems Appendix 2. Validation of water systems for pharmaceutical use Appendix 3. Cleaning validation Appendix 4. Analytical method validation Appendix 5. Validation of computerized systems Appendix 6. Qualification of systems and equipment Appendix 7. Non-sterile process validation – revised text reproduced in this Annex 1. Background and scope 背景和范围 2. Glossary 术语 3. Introduction 概述 4. Process design 工艺设计 5. Process qualification 工艺确认 6. Continued process verification 持续工艺确认 7. Change management 变更管理 References 参考文献 ? 1. Background and scope 背景和范围 Further to the Supplementary guidelines on good manufacturing practices: validation, as published in the World Health Organization (WHO) Technical Report Series, No. 937 (1), additional guidelines to support current approaches to good manufacturing practices (GMP) are published here. These guidelines are intended to further support the concept of process validation linked to quality risk management (QRM) and quality by design principles as described by WHO and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). WHO第937号技术报告中公布了GMP增补指南：验证，此外还公布了一些指南来支持现行的GMP实施方法。这些指南意在为WHO和ICH的质量源于设计原则（QbD）和质量风险管理（QRM）提供更多的工艺验证概念支持。 These guidelines allow for different approaches to process validation. The principles described are mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be applicable to active pharmaceutical ingredients (APIs) and sterile products. (See also recommendations in WHO Technical Report Series, No. 957, Annex 2 (2) and WHO Technical Report Series, No. 961, Annex 6 (