4-Cleaning-Validation-.ppt
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1、13-01-20101Cleaning Validation清洗验证13-01-20102Module Outcomes模块成果 State the GMP reasons for cleaning validation陈述清洗验证的GMP原因Interpret regulatory requirements and guidelines解释监管需求及指南Outline a strategy for cleaning validation that complies with cGMPs略述符合cGMPs 的清洗验证策略Apply risk management principles to i
2、dentify cleaning validation parameters应用风险管理原则来确定清洗验证参数13-01-20103Cleaning Validation清洗验证清洗验证Regulatory Compliance Aspects监管和合规方面监管和合规方面13-01-20104Background to Cleaning Validation清洗验证的背景清洗验证的背景FDA published Guide to inspections of Validation of Cleaning Processes-1993 FDA发布情节工艺验证检查指南 1993PIC/S Guid
3、eline to Validation-2004PIC/S 验证指南 2004 Biotechnology industry-cross contamination critical生物技术产业 交叉污染的关键More and more potent drugs being manufactured更多更有效的药物正在被制造Issues:How clean is clean?Does cleaning Validation apply to all products,Should all products be Validated?问题:怎么算是清洁?清洗验证是否适用于所有产品?所有产品都要经
4、过验证吗?13-01-20105GMP Requirements Cleaning ValidationGMP要求要求 清洗验证清洗验证Cleaning Validation should be performed in order to confirm the effectiveness of a cleaning procedure.应当实施清洗验证去证实清洗程序的有效性 13-01-20106GMP Requirements:Cleaning ValidationGMP要求要求 清洗验证清洗验证Cleaning validation should confirm the effectiv
5、eness of a cleaning procedure.The rationale for selecting limits of carryover for:清洗验证要证实清洗程序的有效性Product residues,cleaning agentsµbial contaminants should be logical,based on the materials involved以相关原料为基础,产品残留物、清洗剂、微生物污染物应该符合逻辑 Limits should be achievable and verifiable所定的限度应该是可以实现的并且可以验证的Suit
6、ably sensitive and validated methods should be used to detect residues at the established acceptable level运用恰当的敏感的、经过验证的方法去检测残留物,使其控制在既定的可以接受的水平Validate direct product contact surfaces(but also consider non contact surfaces)验证直接与产品接触的表面(还要考虑非接触表面)Validate the interval from use cleaning(dirty hold ti
7、me)验证从使用到清洗的间隔时间(脏维持时间)Validate the interval from cleaning to reuse(clean hold time)验证从清洗到再次使用的间隔时间(清洗保持时间)13-01-20107GMP Requirements:Cleaning ValidationGMP 要求要求-清洗验证清洗验证Validation of the worst case of similar materials and cleaning Procedures&processes is allowed相似材料、清洗程序和工艺的最坏情况分析验证是被允许的Validatio
8、n of 3 consecutive runs of the cleaning procedure should be performed3个连续的清洗程序的验证应当被实施Test until clean is not an appropriate alternative“化验至合格”不能代替清洁验证Products which simulate the physicochemical properties of the substance residues can be used where those materials are toxic or hazardous和残留物具有相似理化性质
9、的产品可用于具有毒性的材料上。13-01-20108GMP Requirements:Cleaning Validation GMP 要求要求-清洗验证清洗验证Facilities,systems,equipment and processes,including cleaning,should be periodically evaluated to confirm that they remain valid.对设施、系统、设备和工艺包括清洗,都要进行定期验证以确保它们维持在验证状态13-01-20109Regulators View监管机构的观点监管机构的观点FDA expects fi
10、rms to have written general procedures on how cleaning processes will be validated,FDA要求公司有书面的关于清洗验证是如何进行的通用程序FDA expects the general validation procedures to address who is responsible for performing&approving the validation study,the acceptance criteria and when revalidation will be required.FDA要求
11、常规验证程序说明谁负责执行和批准验证研究,谁负责验收标准和什么时候进行再验证FDA expects firms to prepare specific written validation protocols in advance for the studiesFDA要求公司提前为研究提供具体的书面验证方案FDA expects a final validation report which is approved by management and which states whether or not the cleaning process is valid.FDA要求通过管理而得出的最
12、终的验证报告,该报告说明清洗工艺是否有效FDA Guide to Inspections Validation of Cleaning Processes 1993(section 3,General Requirements)FDA清洗过程验证检查指南 1993(第3部分,常规要求)13-01-201010Other Guidelines&Sources used for Cleaning Validation outside the Regulatory Framework监管框架之外的其它的清洗验证的指南和来源13-01-201011Industry Guidance Documents
13、 行业指导文件行业指导文件 Recommendations on Validation Master Plan,Installation and Operational Qualification,Non-Sterile Process Validation and Cleaning Validation.关于验证主计划、安装和操作确认、非无菌工艺验证和清洁验证的建议 13-01-201012Industry Guidance Documents(2)行业指导文件(行业指导文件(2)Technical Report No.29-Points to Consider for Cleaning V
14、alidation技术报告第29 清洗验证要考虑的要点 13-01-201013Cleaning Validation Principle清洗验证原则清洗验证原则Validation of the cleaning methods provides the documented evidence that the use of an approved cleaning procedure will provide clean equipment suitable for use in manufacturing Pharmaceutical products.清洗方法的验证提供了书面证据,证明
15、经验证的清洗程序将为医药产品的生产提供合适的清洁的设备13-01-201014Cleaning Validation Objective清洗验证清洗验证 目标目标 The objective of cleaning validation is to prove that the equipment is consistently cleaned from product,detergent and microbial residues to an acceptable level to prevent possible contamination&cross-contamination.清洗验
16、证的目的就是要证明设备始终是清洁的,从产品、洗洁剂、微生物残留到可接受的水平,以防止可能的污染和交叉污染 The objective of the cleaning validation is the confirmation of a reliable cleaning procedure so that analytical monitoring maybe omitted or reduced to a minimum in the routine phase.“清洗验证的目的就是要证实一个可靠的清洗程序,这样可以将常规阶段的分析检测省略或者降低到最小程度 13-01-201015An
17、Assumption一个假设一个假设The Equipment cleaning process is already defined in sufficient detail and approved for use.设备的清洗工艺已经被详细的定义并且被批准使用If this assumption is not valid then redevelopment of the procedure should be done followed by retraining of personnel responsible for their implementation如果这个假设是无效的程序,
18、然后重建工作应遵循由负责人员实施再培训13-01-201016Types of Cleaning Processes清洗工艺类型清洗工艺类型Automated&Semi Automated Cleaning-such as clean in place(CIP)cleaning processes for:Piping systemsMixers,tanks and blenders(spray ball)GMP component dishwashing machinesLaboratory glassware washersGMP washing machines(fluid bed dr
19、yer bags etc)Manual equipment cleaning processesComponent disassembly then manual soak&cleanFree standing equipment;Mixers,tanks and blendersTransfer hoses自动和半自动清洗-例如现场清洗工艺:用于以下清洗:管道系统混频器,水槽和搅拌机(喷涂球)GMP清洗机(流化床干燥机袋等)手动清洗工艺设备组件拆卸然后手动浸泡和清洗浮放设备、混合器、水槽和搅拌机转运软管13-01-201017Cleaning Considerations清洗应注意的问题Cl
20、eaning Process清洗过程:1.CIP-repeatable process using a defined control recipes contained in a PLC control systemCIP-用包含在PLC控制系统中的一个确定控制配方的可重复的工艺2.Manual-variable process based on condition of equipment such as bottle brushes,doodlebugs,high pressure Gurney water hose systems.Sink soaking and washing Ti
21、mes by operator手动-随着设备的变化例如瓶子刷子、高压“格尼”水软管系统、水槽浸泡、清洗时间,通过操作者来改变。Considerations注意事项:1.Process&equipment has to be qualified for worst case product and soil load(i.e.solubility index or known historical problems)工艺及设备必须经过最坏情况的确认及土壤负载确认(溶解指数或已知的历史问题)2.Dependent on the individual operator(knowledge,proce
22、dure training,attention to detail)依赖于个体操作者(知识、程序培训、细节的注意)13-01-201018Equipment cleaning questions设备清洗的问题How many validation studies are sufficient to determine process repeatability?多少验证能足够的证明工艺的可重复性?What sort of ongoing,routine monitoring is required?需要什么样的持续的、常规的检测?一Failures should be used to impr
23、ove the SOP&monitor the effectiveness of individual operators失败应该别用来提高SOP和检测个别操作者的有效性一Certain aspects of equipment design may need to be reconsidered(with repeated failures)设备的某些方面可能需要重新考虑Are the proposed cleaning agents compatible with the active&excipient materials being cleaned away?这些清洗剂连同活性物质和赋
24、形剂都一同被清除掉吗?13-01-201019Cleaning validation strategy 清洗验证策略Does cleaning validation have to be done on all products?Usually No Does cleaning validation have to be done on all equipment?Usually YesCan acceptance limits be set for individual pieces of equipment?Usually NoHow do you decide and justify t
25、he amount you do?Prepare a Gleaning VMP with clear objectives所有产品都要经过清洗验证吗?通常不是所有的设备都要经过清洗验证吗?通常是可以接受的限度是为设备的各个部分设定的吗?通常不是如何确定你做的多少?准备一个有主要目标的清洗验证主要计划13-01-201020Cleaning Validation-Key Points清洗验证-要点Require a protocol and written report需要一个协议和书面报告Manufacturer to justify the limits selected for clean
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