Publication of the draft coincides with and complements the release of European Medicines Agency (EMA) guidelines on real-time release testing (RTRT). As with the RTRT document, the EMA uses ICH (International Conference on Harmonisation) work as a starting point for its process validation draft.
“The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification (CPV) in addition to, or instead of, traditional process verification”, the EMA wrote in its draft .
Monitoring needed to support CPV generates data. Using this information a manufacturer can make adjustments during production to maintain drug quality or guide decisions around future process improvements.
“If appropriate, the product may benefit from a defined period of enhanced sampling and monitoring to help increase process understanding as part of continuous improvement”, the EMA wrote. Firms taking this approach should include a discussion of the process in the dossier sent to the EMA.
Best of both
While acknowledging the potential benefits of CPV the EMA continues to support use of traditional process validation too. A hybrid approach, using elements of CPV and process validation, is also an option.
“A justification for using this hybrid approach should be presented in the dossier and it should be clear which approach to validation has been taken for which part of the manufacturing process”, the EMA wrote.
The guideline is aimed at manufacturers of finished dosage forms but contains information that could help API (active pharmaceutical ingredient) producers. Similarly, the principles can apply to biologics but “the complex nature and inherent variability” of these products necessitates a careful approach.