EMA Attempts To Support Continuous Process Verification With New Guidelines

The European Medicines Agency (EMA) has released draft guidelines regarding continuous process verification (CPV) to bring its policies in line with ICH Q8, Q9, and Q10.  The goal is to gain information a manufacturer can use to make adjustments during production to maintain drug quality, “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.  While the EMA has acknowledged the benefits CPV can provide, it also says a hybrid approach using traditional process validation is also an option.  To read more, click here.  To view the EMA’s draft guideline, click here.