2014年4月世卫组织发布修改其非无菌工艺验证指南草案第一稿WHO publishes second D...

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在2014年4月世卫组织发布修改其非无菌工艺验证指南草案第一稿。评论的第一draftfrom2014年4月现在已经流入第二个。这是显而易见的，在一个点或另一个。
表的内容和范围都保持不变。然而，工艺验证的定义包含在词汇已经是生命周期方法。相比第一稿，新版本现在也解释了矩阵方法或包围。
尽管如此，引进提到不同的可能性，工艺验证（与传统的生命周期方法对混合动力）。流程图“可能”是有帮助的。在引入结束时，流程图打算说明该过程验证的生命周期。现在，在图中提到“验证过程”已经在工艺设计阶段。
在工艺设计本章包括比第一稿没有大的变化。
在章节“过程中的资格”，风险评估需要在批量大小的变化，从规模到商业批量大小。明确地说，制造商被要求实施新的验证方法。然而，提到全面实施可能需要一段时间。在此期间，传统的做法或并发确认可以接受。也有混合的方法（基于科学依据和风险管理原则）可能是一个选择。
相比第一稿，章节“持续工艺验证”和“变更控制”并没有显著改变。
结论：显着地大于第一个更严格的第二草案。该文件是一个有点FDA的指导原则对工艺验证和EMA的工艺验证指南的组合，其中的条款使用来自FDA的指导。这两个文件也列在参考文献。一些矛盾依然存在。主题风险评估，QRM和风险为基础的方法是出现在文档中的非常不同的方式。章“的背景和范围，”建议以风险为基础的方法。风险评估被称为“应该”的要求，QRM而为“锦上添花”（“申请QRM时......”）。流程图不应只命名为“可能”的要求。在对工艺验证生命周期（背景/目标）的流程图下的工艺设计命名的工艺验证是针对词汇的定义，根据其工艺验证包括整个生命周期。此外，提同时验证作为替代的生命周期方法可能会被误解。
令人震惊的是ICH Q10并没有被提到，虽然本文件中的某些元素（如不断提高，产品生命周期）已被使用。WHO publishes second Draft on the Revision of its Process Validation Guideline

In April 2014 WHO published a first draft to revise their Non-sterile Process Validation Guideline. Comments to the first draftfrom April 2014 have now flowed into the second one. This is obvious at one point or another.
The table of contents and the scope have remained unchanged. Yet, the definition of process validation contains the life-cycle approach in the glossary already. Compared to the first draft, the new version now also explains the matrix approach or bracketing.
Still, the introduction mentions different possibilities for process validation (traditional vs. life-cycle approach vs. hybrid). A flow diagram "may" be helpful. At the end of the introduction, a flow diagram intends to illustrate the process validation life-cycle. Now, the diagram mentions "validate process" already at the process design stage.
The chapter on process design contains no major changes compared to the first draft.
In the chapter "process qualification", a risk assessment is required for the change in batch size from scale up to commercial batch size. Explicitly, manufacturers are requested to implement the new validation approach. However, it is mentioned that full implementation may take time. In the interim, the traditional approach or concurrent validation may be accepted. Also a hybrid approach (based on a scientific basis and risk management principles) may be an alternative.
Compared to the first draft, the chapters "continued process verification" and "change control" haven't changed significantly.
Conclusion: The second draft is considerably more stringent than the first one. The document is a bit of a mix of FDA's Guidance on process validation and EMA's process validation guideline where the terms used come from the FDA Guidance. Both documents are also listed under references. A few inconsistencies remain. The topics risk assessments, QRM, and risk-based approaches are seen in very different ways in the document. The chapter "background and scope" recommends a risk-based approach. Risk assessments are referred to as "should" requirements, QRM rather as "nice to have" ("when applying QRM..."). A flow diagram shouldn't be only named as "may" requirement. Naming process validation under process design in the flow diagram for the process validation life-cycle (background/objective) is against the definition in the glossary according to which process validation include the whole life-cycle. Moreover, mentioning concurrent validation as an alternative to the life-cycle approach could be misunderstood.
It is astonishing that ICH Q10 hasn't been referred to although some elements of this document (e.g. continuous improvement, product life cycle) have been used.

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yuansoul

wujia19832008 发表于 2014-10-9 16:00
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可以，我认为你的评价很正确。

syhorchid

关注一下

云水风度

值得关注。

野性之吻

希望有跟踪报道

雨晨

为啥在WHO官网找不到相关信息？