关于legacy systems回顾性验证，到底需不需要URS

beiwei5du

各位蒲友：
1、针对于legacy systems（就是针对于新法规没有出来前，按照以前法规进行验证的的系统，验证资料不完备，比如缺少URS），在做回顾性验证时候，需不要URS呢（下面的问答如何理解呢）？？？
2、还有按照法规程序（当然不是灵活的方法），针对于在设备没有建立URS就开始后期的活动的情况，应该怎么处理，按照偏差处理的话，URS是否能进行后期制定(但是URS的日期仍标注实际制定时间，解释说明后，按照URS制定时间重新进行DQ,FAT,SAT,3Q操作，前期未经过允许活动作废)？？

觉得这个回答还可以：

Hi Rich
Raise a validation plan for the move. In it discuss and justify the actions you consider to be required.
The regulators have moved on from the stage where you might get away with just IQ/OQ/PQ.
The preferred definition for 'Validation'; is now given as 'the verification that the users requirements have been fully satisfied'.
Obviously that means if you do not have a properly constructed and detailed URS, then your validation is flawed right from the start.
Control the development of all your documents using a matrix and raise VP/DQ/VRA/IQ/OQ/P1Q/P2Q. The cGMP regulations and requirements make each one of these documents, with the exception of the VP, mandatory.
It is amazing how simple it is when you just follow the regulations.
Regards
Alex Kennnedy

beiwei5du

但我有个问题，是不是要DQ呢？[/quote]
但是有查询到WHO对某公司针对于旧设备的利用，未制定URS，同时WHO检查官员也没有提出异议。

hoover

legacy systems验证的特点就是尽可能利用现有的资料，该有的验证活动都要有，与新项目区别不大。
英文回答是很对的，先有URS，再做差距分析。

半世流离

不太懂，URS应该要吧

cnosema

一沙一叶

我也同意需要URS，这样才能便于3Q进行  

一沙一叶

但我有个问题，是不是要DQ呢？

gaojiaoqing

我认为DQ需要，广义上说，DQ存在各个阶段。

beiwei5du

在另一份2014年针对于重庆华方武陵山药业的WHO检查报告中也提到这个问题（该厂为迁址重建项目），大家怎么认为？？？

beiwei5du

hoover 发表于 2016-6-30 12:13
legacy systems验证的特点就是尽可能利用现有的资料，该有的验证活动都要有，与新项目区别不大。
英文回答 ...

In previous paragraphs, the term engineered system was underlined.  Many organizations erroneously require that all systems on site require a URS.  This is a mistake and demonstrates a poor understanding of the purpose of a URS.  In light of using a URS for QbD it does not make sense to generate a URS for a piece of equipment or an instrument purchased from a catalogue or off-the-shelf.  It is difficult to design quality into something that is not being designed.  The appropriate approach for off-the-shelf equipment is to employ a risk or impact assessment in lieu of a URS.  Another approach is to use a general purchase policy to identify requirements for items such as laboratory instrument.  Such a policy might include Part 11 requirements, purchased qualification packages and/or specific FDA requirements.

Retrospection

Many organizations decided to retrospectively generate URSs for equipment and systems that are already in place or which are already designed and built to “check the box” on the regulatory requirement.  Retrospectively generating a URS signals to an auditor that QbD was accidental and that the organization has not fulfilled the intent of QbD.  Retrospection is non-value-added, so if a project is already past design/build, it makes more sense to perform risk and impact assessments.  This is a check on commissioning and qualification documentation to verify each CTQ item.  Policies and procedures that allow risk and impact assessments for existing systems and URS and DQ at the beginning of a new project saves time and stays true to the intent of a DQ and URS.

An Overview to User Requirement Specifications and Design Qualification
这个各位老师是如何理解的呢？？？？

beiwei5du

FYI