The evaluation of data with regard to criticalityis essential and - to some extent - no trivial activity.Data must be evaluated in particular with regard to patient safety and/orproduct quality.

对数据关键性的评估是必不可少的 - 在某种程度上– 意义非凡。尤其必须评估与患者安全和/或产品质量相关的数据。

The term critical data appearsat only one place in the EU GMP Guidelines:

“关键数据”一词仅出现在欧盟GMP指南的一个地方:

4.27 - A system should be in place toindicate special observations and any changes to critical data.

“4.27 - 应建立一个系统来指明特定的问题和关键数据的任何变化。”

The EU GMP Annex 11 also mentions criticaldata at only one place.

欧盟GMP附录11也仅在一个地方提到关键数据。

6. Accuracy Checks - For criticaldata entered manually, there should be an additional check on the accuracy ofthe data.

“6.准确性检查 - 对于手动输入的关键数据,应该对数据的准确性进行额外检查。”

This provides a legal basis for reviewingthe entry of critical data. A second person must therefore verify it. Analternative would be a validated computerised system.

这为审核关键数据的输入奠定了法律基调。因此,必须由第二人确认。另一种选择是经过验证的计算机化系统。

Example:

例如:

The temperature is measured in a stirringtank. This measurement is part of the batch report and is relevant for release.The temperature is read manually and documented manually. In this case, asecond person is required to check the correctness of the data (double-checkingprinciple).

在搅拌罐中测量温度。此测量是批次报告的一部分,与放行相关。手动读取温度并手动记录。在这种情况下,需要第二个人检查数据的正确性(复核原则)。

Or

或者

The temperature is recorded electronicallyvia a computerised system and saved electronically. In this case, thecomputerised system would have to be validated.

通过计算机系统以电子方式记录温度并以电子方式保存。在这种情况下,必须验证计算机化系统。

Back to the evaluation of data criticality:neither section 4.27 nor Annex 11 (section 6) provides much information aboutwhich data is critical and which is not. There is no legal definition ofcritical data in the GMP environment. If one looks at the various guidelinesand standards in the GMP area, a definition for critical data can be found inVDI/VDE 3516 Part 5 on Validation in the GxP environment - Types of rawdata:

回到数据关键性的评估:第4.27节和附录11(第6节)都没有提供太多关于哪些数据至关重要而哪些数据不重要的信息。GMP环境中没有关键数据的法律定义。如果查看GMP领域中的各种指南和标准,可以在VDI / VDE 3516第5部分“GxP环境中的验证 - 原始数据类型”中找到关键数据的定义:

Critical data:

“关键数据:

Data that has a potential impact on patientsafety, product quality and data integrity.

对患者安全,产品质量和数据完整性有潜在影响的数据”。

It is the decision of the company(medicinal products manufacturer) to define the data to be included.

公司(医药产品制造商)自行定义要包含的数据。

The crucial question is certainly: Is thereany GMP-relevant data which is not critical?

关键问题是:是否有哪些与GMP相关的数据是不重要的?

Figure 1 shows a corresponding example. Athree-level classification makes sense:

图1给出了示例。合理的做法是分为三个等级:

Criticality is high, medium orlow.

关键性高、中、低。

PI 041 GOOD PRACTICES FOR DATA MANAGEMENT ANDINTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS provides information on criticaldata, which also proves their significance.

PI 041提供了关键数据的信息,这也证明了它们的重要性。

Example:

例如:

5.4 Data criticality - For example: for anoral tablet, API assay data is of generally greater impact to product qualityand safety than tablet friability data.

“5.4数据关键性 - 例如:对于口服片剂,API测定数据通常对产品质量和安全性的影响大于片剂脆碎度数据”。

The document stresses the importance of data interms of its influence on decisions such as the batch release.

该文件强调了数据在批放行等决策影响方面的重要性。

5.4 Data criticality

“5.4数据的关键性

5.4.1 The decision that data influences may differin importance and the impact of the data to a decision may also vary. Points toconsider regarding data criticality include:

5.4.1数据影响的重要性和数据对决策的影响可能会有所不同。有关数据关键性的考虑因素包括:

Which decision does the data influence?

数据影响哪个决策?

For example: when making a batch release decision,data which determines compliance with critical quality attributes is normallyof greater importance than warehouse cleaning records

例如:作批放行决定时,用以证实符合关键质量属性的数据通常比仓库清洁记录更重要”