EMA Releases Draft Guideline on Process Validation

The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, Q9 and Q10 documents on continuous process validation.

Process validation, which EMA defines as "documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes," is done to ensure manufacturing consistency.

"Process validation should not be viewed as a one-off event," explains EMA in its 13 April Draft Guideline on Process Validation.   "A lifecycle approach should be applied linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production."

The draft guidelines goes on to describe elements that should go into the formulation of a company's process validation procedures, including differences between traditional and continuous process verification, possible traditional/continuous hybrid approaches, lifecycle process verification, scale up considerations, post approval change controls and standards of manufacture.

The draft guideline replaces an earlier note for guidance entitled, Note for Guidance on Process Validation.

Consultation on the draft is open until 31 October 2012.

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