On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously: GMP inspection practice, process and validation, and challenges for EU harmonisation. I somehow found myself listening to Lina Ertle from the French national agency for medicines and health products (ANSM), who gave an update on process validation guidelines.
“Process validation has never been a one-time event, and EU GMP requests that processes in use for some time be revalidated in Annex 15, Chapter 5,” Lina Ertle said at the start of her talk. Terminal sterilisation, for example, should be revalidated at least once a year, while equipment qualification, such as tabletting and filling machines, requires validation on an ongoing basis. Ertle shared on the concept of process validation lifecycle using a systematic approach that takes into account risk analysis, design of experiments, control strategy, as well as critical parameters and quality attributes.
Those unfamiliar with the topic, such as the likes of me, were enlightened about the difference between continuous and continued process verification. The former is an alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated whereas for the latter, the goal is to continually assure that the process remains in a state of control (i.e., the validated state) during product lifecycle. Oh, the joys of understanding the English language.
Stephan Ronninger from F. Hoffmann-La Roche, whilst speaking about the ICH landscape in relation to process validation, shared about his experience explaining to the Japanese regulators and industry the difference between these definitions, which apparently is quite a challenge to translate into Japanese. At the end of the day, he said, we must remember that the main objective of process validation is to confirm that a process will consistently yield a product meeting its pre-defined quality criteria.