EMA Guideline on Process Validation
| 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. |
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