WHO publishes Draft on Process Validation2014版工艺验证草案.doc

WHO publishes Draft on Process Validation WHO公布工艺验证草案 Dated April 2014 the WHO published a proposal for a revision of appendix 7(non-sterile process validation) as a supplementary to the Guidelines on GoodManufacturing Practices. The reason given for the revision is compliance withactual GMP requirements. Explicitly mentioned are quality risk managementprinciples and quality by design principles with references to WHO and ICHrequirements. The text is mainly applicable to non-sterile finished pharmaceuticaldosage forms. According to the draft similar approaches may be applicable toactive pharmaceutical ingredients (APIs) and sterile products. The WHO now alsoputs the focus of validation on the life-cycle of process validation whichconsists of:2014年4月，WHO公布了GMP指南附录7的修订意向（非无菌工艺验证）。修订是为了符合实际的GMP要求，其是明确提到质量风险管理原则和质量源于设计原则，以及对WHO和ICH要求的引用。文件主要适用于非无菌制剂。根据草案，类似的方法也适用于原料药和无菌药品。WHO现在也关注生命周期的工艺验证，其中包括· product and processdevelopment · 产品和工艺研发· validation of thecommercial manufacturing process· 商业生产工艺的验证And以及· maintaining the processin a state of control.· 保持工艺受控A risk-based approach and the use of in-line, on-line and/or at-linecontrols is recommended expressly.推荐基于风险的方法，使用在线控制。The 16s-draft consists of 7 chapters and the references:这份16页的草案包括7个章， 以及参考文献1. Background and scope 背景和范围2. Glossary 术语3. Introduction 介绍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 control 变更控制References参考文献Glossary 术语A part of the terms in the glossary has been taken over verbatim from theICH Guidelines and the FDA Process Validation Guidance. It is striking that theterm process validation is quoted in the glossary still in the old version(documented evidence that a process...). The reference to the life-cycleapproach is missing completely here. The matrix approach can be found as a termbut without any further explanations.术语中的有些词是从ICH指南和FDA工艺验证指南照搬的，引人注目的是所引用的术语“工艺验证”仍来自于旧版本（“书面证据证明一个工艺……”）。生命周期方法的引用则完全没有。矩阵方法被作为了一个术语，但