EMA guidance on process validation

Final text now issued!

Further to the publication of a consultation draft revision of the guidance on process validation in March 2012, the document has now been finalised (February 2014) and may be found at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162136.pdf

The document comes into effect six months from the publication date.

This replaces the previous (2001) guidance on process validation and brings it into line with ICH Q8, Q9 and Q10.

The major change is that “the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged … applying enhanced process understanding coupled with risk management tools under an efficient quality system”.