20141217 ECA新闻 常见GMP问题：验证方案/报告需要多少个签名？

20141217 ECA新闻 常见GMP问题：验证方案/报告需要多少个签名？  

2014-12-18 14:26:53|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272014111822653818/

GMP News
17/12/2014

Frequent GMP Question: How many Signatures are required for Validation Protocols/ Reports?

常见GMP问题：验证方案/报告需要多少个签名？

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? What is the responsibility of the Head of Production and the QA department in this matter?

作为药品生产中验证和确认活动的一部分，以下问题经常被问到：在相关的方案和报告中，需要有多少个签名？在这方面生产负责人和QA部门负责人的职责是什么？

Indications can be found in the chapters 1, 2 and 4 of the EU GMP Guide Part I. You can find in Chapter 4 requirements on the topic "Documentation":

在EU GMP指南第1部分的第1、2和4章中，可以看到相关文字。你可以在第4章对“文件”的要求中看到：

4.2. "Documents should be designed, prepared, reviewed, and distributed with care."

4.2.“文件应认真设计、起草、审核和发放”
4.3. "Documents containing instructions should be approved, signed and dated by appropriate and authorised persons."

4.2.“包含有指令的文件应经过批准，由具有授权的适当的人员进行批准和签名日期”。

This can be summarized as follows: each document should have one author, one reviewer and one approver. The Head of Production is responsible for the qualification of his equipment and the validation of his processes (Chapter 2.7 (4)); the same applies to the Head of QC in the lab (2.8.).

这可以总结如下：每份文件均应有一个作者、一个审核人和一个批准人。生产负责人负责其设备的确认和工艺的验证（第2章2.7条第（4）款）；同样这也适用于化验室设备确认时QC的负责人（2.8条）。

Since the introduction of the revised Chapter 2 in February this year, a new point has been added. Moreover - depending on the size and the organisational structure of the company - an independent Head of Quality Assurance or Quality Unit can be assigned. Where such a function exists usually some of the responsibilities described in 2.6, 2.7 and 2.8 are shared with the Head of Quality Control and Head of Production. Senior management should therefore take care that roles, responsibilities, and authorities are defined. This means for example that the QA can assume the tasks of the Head of Production. Basically, the QM system should ensure that validation is performed (1.4 (10)).
由于今年2月对第2章进行了修订，增加了新的要求。另外，根据公司组织结构的规模—可以任命独立的质量保证负责人或质量部门负责人。如果该功能已经存在，通常2.6、2.7和2.8中的职责会由质量控制负责人和生产负责人来分担。高层管理应对各职位的角色、职责和授权进行界定。这就意味着，例如，QA可以承担生产负责人的任务。原则上来说，质量管理体系应保证验证的实施（1.4（10））。
Conclusion: Depending on your internal structure, you can specify the signature rules. You should be aware of what "approved" and "released" mean as both can have various meanings. "Approved" can be used for a document, for a technical review, for execution, or can even have a completely different meaning in conjunction with other terms. Similarly, depending on the term you use in combination with "released" its meaning is different, as, i.e., released formally or textually. Some companies set such definitions in a SOP documentation.
结论：根据你们的内部组织结构，你可以指定签名的要求。你应该明白“批准”和“放行”的意思，因为这两个词都的意思都根据环境有不同的意思。“批准”可以用于文件、技术审核、执行，甚至与其它术语结合的时候有完全不同的意思。类似的，根据你与“放行”一词一起使用的其它术语的意思不同，“放行”的意思也有所不同，也就是说，正式或文字上的放行。有些公司在SOP文件中给出了定义。
Finally, the GMP Guide gives the freedom to do it otherwise; if you - at least - come to the same conclusion and can prove it.

最后，GMP指南给出了采用其它方式的自由，如果你----至少----得出同样的结论，则可以对其进行证明

In the US, the procedure is slightly different. There, the personal responsibility of the Head of Production / QC is not part of the GMP regulation. On the contrary, it is the QCU who has a crucial role.

在美国，程序有点不太一样。那里，生产/QC的人员职责不是GMP法规的一部分，相反，QCU是关键的角色。

The American Society of Testing and Materials (ASTM) has a quite different approach. The document ASTM E 2500 defines "Subject Matter Experts" for qualification. According to this model, the QA department would only sign superordinate qualification documents. This is an interesting and lean approach although not very common Europe yet.

美国材料试验协会（ASTM）的方法则有很大差异。ASTM E2500中对确认的“目标问题专家”进行了定义。根据该模式，QA部门则只能对确认的高层级文件签字。这很有意思，在欧洲还不同很常见。