（转）20180530 ECA新闻：计划外偏差：QP的职责是什么？

花落知多少

30.05.2018 Julia法规翻译  

Unexpected deviation: what is the Role of the QP?计划外偏差：QP的职责是什么？

The EuropeanMedicines Agency EMA has updated its Questions and Answers Section with anamendment to further clarify the role of the Qualified Person (QP) in thecontext of handling unexpecteddeviations.

EMA刚更新了其问答部分，对QP在计划外偏差处理中的职责进一步做了说明。

Annex 16 to the EU-GMPGuidelines (Certification by a Qualified Person and Batch Release)  statesin section 3 that "providedregistered specifications (…)  are met, a QP may consider confirmingcompliance or certifying a batch where an unexpected deviation concerning themanufacturing process and/or the analytical control methods from detailscontained within the MA and/or GMP has occurred". But whatexactly are "registeredspecifications"? And can we deviate from in-process controls?

EU GMP指南附录16（QP认证和批放行）在第3部分声称“当生产工艺和/或分析方法在计划外情况下偏出MA注册内容和/或GMP要求时，如果该批次仍符合注册的质量标准（……），QP可以考虑确认符合性或认证该批次”。但确切地说，什么是“注册标准”？我们是否可以偏出中控要求？

This is answered inone of the Q&As: "Registeredspecifications for medicinal products include in-process, bulk and finishedproduct specifications which have been included in the MA application."

这个问题在问答中得到了回答：“注册药品标准包括MA申报资料中所包含的中控、散装和包装完成的成品标准”。

However, thecriticality of registered in-process specifications "may vary depending on the qualityattribute tested, the impact to subsequent manufacturing processes and abilityto test the quality attribute in the finished product". So depending on arisk assessment, it might be possible to accept deviations from in-processspecifications. As a pre-requisite, the risk assessment performed must confirmthat there is "no impact to manufacturing process or product quality".

但是，注册中控标准的关键程度“可能会依所测质量属性、对后续生产工艺的影响以及成品质量属性检测能力不同而不同”。因此，根据风险评估情况，有可能可以接受中控质量偏差。作为前提条件，所执行的风险评估必须确认“对生产工艺或产品质量并无影响”。

The EMA emphasisesthat non-compliance with registered product specifications fall outside thescope of Annex 16 section 3. That means that a QP will not be able to certifyan affected batch.

EMA强调说不符合注册的产品质量标准不在附录16第3部分的范围内。这意味着QP不可能认证这样受影响的批次。

What happens, if morethan one batch affected by the same unexpected deviation?

如果不止一个批次受到相同的非预期偏差影响，会发生什么事情？

In this case, itwould be acceptable to certify the batches if they have "already been manufactured and/ortested at the time of discovery of the unexpected deviation".

在此情形下，如果这些批次“在发现计划外偏差时已经生产结束和/或检测完成”，则可以接受对它们的认证。

For batchesmanufactured after the discovery, these then repeated deviations should beconsidered to be a change. As a consequence, "variations to the affected marketing authorisations must be submitted".In "exceptionalcircumstances" and to avoid disruption to supply, it "may be possible to continue QP certification while corrective and preventive action is in progress".

对于在发现之后所生产的批次，则应将这些重复偏差作为一个变更。后续应该“针对受影响的上市许可提交变更”。在“例外情形下”并且为了避免破坏供应情况，“当CAPA正在进行时，QP可以继续认证产品”。

For furtherinformation please also read the EMA Questions and Answers Section.

更多信息，参见EMA问答部分。

贝多芬的画笔

好像有版主发过，有没有大神来分析分析

hhxx2018

敬请大神分析。

wsx

What is an ‘unexpected’ deviation?
The process itself should be designed to comply with the registered requirements (fit for purpose). A deviation can be considered as ‘unexpected’ until the time of discovery. Where the relevant authorities have confirmed the need to avoid supply disruption, repeat deviations thereafter are no longer ‘unexpected’ but may be considered for QP certification and accepted while corrective and preventive action is in progress and where the provisions of Annex 16 paragraph 3.1 are met.

Planned deviations or deviations that are caused by incorrect communication between marketing authorisation holder (MAH) and manufacturers (e.g. if the MAH fails to notify the manufacturer of relevant changes to the MA) are outside the scope of the paragraph 3.1. The marketing authorisation holder should submit an application for a variation to the marketing authorisation, if needed.

‘unexpected’ deviation和Planned deviations，这两个定义谁给个确切的解释？为什么有这两个定义，而不是直接的deviation？  是不是特指 in-process specifications。

kulak90

计划偏差不是变更么