欧盟GMP附录15征求意见稿与颁布稿的变化

稚子

附录15终稿		附录15草稿
章节	条款	章节	条款
通则	Retrospective validation is no longer  considered an acceptable approach.    。回顾性验证不再    被认为是可以接受的方法。
1.5	v.   Guidance on developing acceptance criteria;    v.   可接受标准建立指南	1.5	d) Template formats to be used for  protocols and reports.    e) Planning and scheduling.    g) Handling of acceptance criteria    i) An assessment of the resources  required.    k) Confirmation that the materials used  for validation are of the required quality and    suppliers are qualified to the  appropriate level.      d)   用于方案和报告的模板      e)   计划和日程安排      g)   可接受标准      i)   所需资源的评估      k)   确认验证所需的材料符合质量要求并且供应商是符合适当的级别
1.10	Appropriate checks should be incorporated  into qualification and validation work to ensure the    integrity of all data obtained.    应将适当的检查结合进确认和验证工作，以保证所获得的数据的完整性
2.5	Qualification documents may be combined  together, where appropriate, e.g. installation qualification    (IQ) and operational qualification (OQ).    确认文件在适当时可以合并在一起，例如，安装确认（IQ）和运行确认（OQ）。
2.6	Where validation protocols and other  documentation are supplied by a third party providing    validation services, appropriate  personnel at the manufacturing site should confirm suitability and    compliance with internal procedures  before approval. Vendor protocols may be supplemented by    additional documentation/test protocols  before use.    2.6. 如果验证方案和其它文件记录由验证服务第三方提供，则应由生产场所的适当人员对文件记录    的适用性进行确认，在批准前确认其符合内部程序。供应商方案在使用前可以进行文件记录/    测试增补。	2.5	2.5 Where validation protocols are  supplied by a third party, the manufacturer should    confirm suitability and compliance with  company procedures before approval.    当验证方案由第三方提供，在批准之前生产商要确认符合公司的程序。
3.8	IQ  should be performed on equipment, facilities, utilities, or systems.    设备、设施、公用系统或系统应进行安装确认。	3.8	IQ  should be performed on new or modified facilities, systems and equipment. 新的或更改的厂房、系统和设备需要进行IQ。
4.0    4.1    4.2	RE-QUALIFICATION    再确认    Equipment, facilities, utilities and  systems should be evaluated at an appropriate frequency to confirm    that they remain in a state of control.    设备、设施、公用系统和系统应以适当的频次进行评估，以确认其仍处于受控状态。    Where re-qualification is necessary and  performed at a specific time period, the period should be    justified and the criteria for evaluation  defined. Furthermore, the possibility of small changes over    time should be assessed.    如果需要在一个特定时间周期内进行再验证，则应对该时间周期进行论证，并确定评估的标准。    另外，应评估在此期间进行小型变更的可能性。	10	RE-QUALIFICATION再确认    Facilities, utilities, systems, equipment  should be evaluated at an appropriate frequency to confirm that they remain  in a state of control.    Where additionally re- qualification is  necessary and performed at a specific time period, the period should be justified  and, the criteria for evaluation defined.    Furthermore the possibility of  incremental changes should be assessed.    Where manual processes are used, such as  for cleaning of equipment, the continued effectiveness of the process should  be confirmed at a justified frequency.    厂房、设施、系统、设备应以一定的频率进行评价来确认它们处于控制状态。    10.2   当需要额外的再确认并在特定时间执行时，要说明验证周期的合理性，要确定评价的标准。      10.3   当使用人工操作工艺时，例如清洁设备，需要以一个合理的频率来确定这个工艺持续有效。
5.1	……It is implicit in this annex that a  robust product development process is in place to enable successful process  validation.    本附录中不言而喻的意思是应有一个坚实的药品研发过程来保证成功的工艺验证。
		4.20	n) Proposed timetable.计划的时间表
		4.29	On going process verification should be  considered where any individual change or successive incremental changes  during the product lifecycle could have an impact on the validated status of  the process.    在产品生命周期中任何单个变化或者后续增加的变化可能对工艺的验证状态有影响，  需要考    虑持续工艺验证。
6    6.2    6.3    6.4	6.   VERIFICATION OF TRANSPORTATION       6.   运输确认      It is recognised that verification of  transportation may be challenging due to the variable factors    involved however, transportation routes  should be clearly defined. Seasonal and other variations    should also be considered during  verification of transport    我们知道对运输条件进行确认可能很难，因为其中牵涉的变动因素太多，但是运输路线应清楚说明。在运输确认中还要考虑季节和其它变量。      A  risk assessment should be performed to consider the impact of variables in  the transportation    process other than those conditions which  are continuously controlled or monitored, e.g. delays    during transportation, failure of  monitoring devices, topping up liquid nitrogen, product susceptibility    and any other relevant factors.    要进行风险评估，以考虑在运输过程中除受到持续控制或监控条件以外的变化的影响，例如，    运输延误、监控装置失效、补充液氮、产品易感性和其它相关因素。      Due to the variable conditions expected  during transportation, continuous monitoring and recording    of any critical environmental conditions  to which the product may be subjected should be performed,    unless otherwise justified.    由于运输期间可预见的条件变化，在运输期间应对产品可能经受的所有关键环境条件进行监控    和记录，另有论证者除外。	5.0    5.2    5.3    5.4	5. ERIFICATION OF TRANSPORTATION    It is recognised that validation of  transportation may be challenging due to the variable factors involved  however transportation routes should be clearly defined. For transport across  continents seasonal variations should also be considered.    A risk assessment should be performed to  consider the impact of conditions other than temperature during  transportation e.g. humidity, vibration, handling, delays during  transportation, failure of data-loggers, topping up liquid Nitrogen, product  susceptibility and any other relevant factors.    Due to the variable conditions expected  during transport e.g. delays at airports, continuous monitoring of any  critical environmental conditions to which the product may be subjected  should be performed.    运输确认      要明确规定运输路线，由于存在可变因素应进行挑战性的运输验证。也要考虑到运输过程季    节的变化。      风险评估中除了考虑温度还要考虑运输过程中的其它条件的影响，如湿度、震动、交接、耽    搁、数据无法记录、产品敏感性和其它相关因素。      由于运输过程中可能出现的变化条件，例如在机场的耽搁，需要对产品可能面临的关键的环
10.3	It is recognised that a cleaning  validation programme may take some time to complete and    validation with verification after each  batch may be required for some products, e.g. investigational    medicinal products. There should be  sufficient data from the verification to support a conclusion that    the equipment is clean and available for  further use.      我们知道清洁验证程序可能需要一些时间来完成，有些产品可能需要在每批生产之后均进行确认，例如，临床前药品。在确认中应有足够的数据来支持设备是清洁的并适用于其未来使用的结论。	9.12	For investigational medicinal products or  products which are only manufactured infrequently, cleaning verification may  be used instead of cleaning validation. If used, cleaning verification after  each batch should be based on the principles in this section of the Annex    对于研究用药品和极少生产的药品，可以使用清洁确认的方式代替清洁验证。
10.6.1    10.6.2	Therapeutic macromolecules and peptides  are known to degrade and denature when exposed to    pH extremes and/or heat, and may become  pharmacologically inactive. A toxicological evaluation    may therefore not be applicable in these  circumstances.    已知治疗用大分子和多肽在暴露于pH极值和/或记温时会降解及变性，可能变得无药物活性。这种情况下可能不适用毒性评估。      If it is not feasible to test for  specific product residues, other representative parameters may be    selected, e.g. total organic carbon (TOC)  and conductivity.    如果测量特定的产品残留不现实，则可以选择其它的代表性参数，例如，总有机碳（TOC）和电导率。
10.15	Where manual cleaning of equipment is performed, it is especially  important that the    effectiveness of the manual process  should be confirmed at a justified frequency.    如果对设备进行手动清洁，则采用论证的频次对手动工艺的有效性进行确认就尤其重要，	9.4	…. Where a manual process is used, an assessment  should be performed to determine the variable factors which influence  cleaning effectiveness, e.g. operators, the level of detail in procedures  such as rinsing times etc…. 对于手工清洁工艺，应通过风险评估确定影响清洁效果的因素，例如操作人员、操作规程的详细程度例如冲洗时间等。

一沙一叶

比对一下啊

liuqygood2005

有心人，学习下，多谢

郦无悔

还是有一些变化的啊, 关注关注, 谢谢!

雪的影子

学些学习~~~~~~

syhorchid

了解一下

lxm0707

有一些新得变化，学习中

woyitianxia

能分析一下就更好了