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《GMP / GDP 环境中数据管理和完整性良好规范》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”