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

GMP News

08/10/2014



In April 2014 WHO published a first draft to revise their Non­sterile 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.

The table of contents and the scope have remained unchanged. Yet, the definition of process

validation contains the life­cycle 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. life­cycle

approach vs. hybrid). A flow diagram "may" be helpful. At the end of the introduction, a flow

diagram intends to illustrate the process validation life­cycle. 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 risk­based 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 life­cycle (background/objective) is against the definition

in the glossary according to which process validation include the whole life­cycle. Moreover,

mentioning concurrent validation as an alternative to the life­cycle 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.10/8/2014 Print GMP-News

http://www.gmp-compliance.org/eca_new_news_print_4535.html 2/2

You can find the second revision draft in ECA's members' area.



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