20141008 ECA新闻：WHO公布工艺验证指南修订第二版草案

20141008 ECA新闻：WHO公布工艺验证指南修订第二版草案  

2014-11-07 09:45:26|  分类： ECA新闻

GMP News
08/10/2014

WHO publishes second Draft on the Revision of its Process Validation Guideline

WHO公布工艺验证指南修订第二版草案

In April 2014 WHO published a first draft to revise their Non-sterile Process Validation Guideline.Comments to the first draft from April 2014 have now flowed into the second one. This is obvious at one point or another.
在2014年4月，WHO公布了其无菌工艺验证指南修订的第一版草案。从2014年4月起，收集的对第一版草案的意见汇整到了第二版中。这或多或少是很明显的。
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.
目录和范围保持未改，而术语中工艺验证定义已含有生命周期方法。与第一版草案相比，新版本现在也解释了矩阵方法或分组法（括号法）。
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.
介绍提到工艺验证的不同可能性（传统VS生命周期方法VS混合方法）。流程图“可能”会有帮助。在介绍的结尾，给出了一个流程图来说明工艺验证生命周期。现在，流程图在工艺设计阶段已提到“验证工艺”。
The chapter on process design contains no major changes compared to the first draft.
与第一版草案相比，工艺设计章保持没有重大改变。
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.
在章节“工艺确认”中，要求对放大至商业批量的批量变化进行风险评估。在这里很明确地要求生产商实施新的验证方法。但是，其中也提到全面实施会需要一定时间。在一定时间内，传统的方法或同步验证是可以接受的。同时，混合方法（基于一种科学基础和风险管理原则）也可以使用。
Compared to the first draft, the chapters "continued process verification" and "change control" haven't changed significantly.
与第一版草案相比，章节“持续工艺确认”和“变更控制”并没有重大改变。
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.
结论：第二版草案明显比第一版草案严格了许多。文件有点像是FDA工艺验证指南和EMA工艺验证指南的混合，其中所用的术语来自FDA指南。两份文件均列为了引用文献，当然仍保留有一些不同之处。在文件中，风险评估、QRM和基于风险的方法看起来差异很大。章节“背景和范围”推荐使用基于风险的方法。风险评估被引用作为“应当”的要求，而QRM则是作为“最好能做”（“如果应用QRM……”）。一个流程图不应该仅被称为“可能”的要求。在工艺验证生命周期（背景和目的）流程图中的工艺设计中对工艺验证选定名称的做法与术语中的定义（根据该定义，工艺难天底下 应包括全部生命周期）是背离的。
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.   
令人惊讶的是尽管使用了ICH Q10中的一些要素，但并没有引用该指南。
You can find the second revision draft in ECA's members' area.

第二版草案可以在会员区找到。

链接来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201410794526496/

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