持续工艺确认怎么做？.doc

持续工艺确认怎么做？
　　一、依据：　　摘录自FDA 行业指南 关于ICH Q8,Q9和Q10的问答　　持续工艺确认(CPV，Continuous Process Verification)概念最早见于ICH Q8，连同生命周期、QBD(质量源于设计，重点词汇：设计空间)概念一并提出。后在FDA制药工艺行业指南2011年版作了进一步的要求。现欧盟GMP附录15《确认与验证》及中国GMP附件《确认与验证》已对它作出了一些要求。但是具体的如何实施并未给出。目前整个行业内大部分制药企业也在摸索和观望阶段。介绍了持续工艺确认(CPV，Continuous Process Verification)的基本方法，以及它与产品年度回顾的区别。供大家参考。CPV的方法　　CPV can usein-line,on-line or at-linemonitoring or controls to evaluate processperformance. These are based on product and process knowledge andunderstanding. Monitoring can also be combined with feedback loops to adjustthe process to maintain output quality. This capability also provides theadvantage of enhanced assurance of intra-batch uniformity, fundamental to theobjectives of process process measurements and controls insupport of real-time release testing (RTRT) can also play a role in CPV.
　　CPV可以使用在位，在线或近线监测和控制来评价工艺性能。这些都是基于产品和工艺的知识和理解。监测也可结合反馈调整工艺来保持输出质量。此功能也为保证批内一致性提供了优势，对实现工艺验证的目标尤为重要。一些用于支持实时放行测试(RTRT)的过程测试和控制程序也可以在CPV发挥作用。　　CPV can enhance the evaluation of the manufacturing process when it providessubstantially more information on process variability and control.　　当CPV对工艺的变异和控制提供了充分的信息后能提高制造过程的评价。　　Some advantages of CPV：　　CPV的一些优点：　　· Replaces the emphasis on the first few commercial-scalevalidation batches with enhanced assurance of product quality in many, or evenall, batches;　　·CPV重在保证很多批次甚至所有批次产品(生命周期内)质量而不是强调最开始的几批商业规模验证批(传统工艺验证)。　　Provides the foundation for a robust processperformance and product quality monitoring system, increasing product andprocess knowledge and facilitation of continual improvement opportunities forprocess and product quality;　　·提供了一个强大的工艺性能和产品质量监控体系的基础，提高产品和工艺的知识和促进对工艺和产品质量的持续改进的机会;　　· Enables earlier detection of manufacturing-relatedproblems and trends;　　·使能够提前预测生产相关的问题及趋势;　　·Provides immediate feedback of the effect of a change,thereby facilitating the management of changes;　　·提供一个对变更效果的及时反馈，从而促进变更管理;　　·Provides a higher assurance of an ongoing state of