EMA publishes Draft on the Process Validation Guideline

On 15 March 2012, the EMA published the long-awaited revision of her Process Validation Guideline. The finalised document will then replace the current valid guideline entitled "Note for Guidance on Process Validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). Comments to the draft can be sent until 31 October 2012.

The draft is composed of 11 pages divided into 8 numbered chapters, one summary, definitions, references and an Annex I.

The document is brought into line with ICH Q8, Q9 and Q10 documents and introduces the possibility to use "continuous process verification" (CPV). It can be used in addition to the "traditional approach" as described in the currently valid guideline, or instead of it. There is also a "hybrid approach" possible. The document expressly points out that this draft doesn't introduce new requirements on medicinal products already authorised.

One particularly interesting note is that process validation shouldn't be viewed as a one-off event and that a lifecycle approach should be used. Basically, product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production should be linked, as well as steps presented in the new FDA Guidance on Process Validation.

Industry and assessors are the target group of this draft and should find support in the document regarding marketing authorisations. It is not directly relevant for manufacturers of APIs or other starting materials. Nevertheless, they may find information useful for their activities. The fundamental principles described in the document are applicable also to biological products, however, under certain conditions.

We will publish a more detailed observation of the topic in one of the next News. Please see the draft "Guideline on Process Validation" for further information.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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