EMA publishes guideline on real-time release testing
Advice expanded from sterilised products to medicines and biomedicines
The European Medicines Agency (EMA) has published guidance for pharma manufacturers on using real-time release testing (RTRT) assessments of processes rather than end-product testing.
Its advice expands existing recommendations, which covered sterilised products, to medicines and biomedicines.
Noting that RTRT systems need to give ‘assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control’, EMA argues they can be more effective than end product tests.
That said, the agency stresses that regulators must retain the authority to decide when real-time testing is appropriate. Furthermore, EMA stressed that manufacturers should not be able to switch to end-product tests if real-time tests highlight a problem, hoping it will go away.
‘In the event that the test results of RTRT fail or are trending toward failure, RTRT may not be substituted by end-product testing. Any failure should be investigated and trending should be followed up appropriately,’ said the EU agency. The guidance stresses that end-product testing will still be required for pharmaceuticals imported into the EU.
The agency also advises on how EU manufacturers should be granted approval for using RTRT. It said: ‘Monitoring of critical parameters/attributes must be capable of demonstrating that pre-determined validated conditions have been achieved throughout the batch.’ Furthermore, it adds, assessors will evaluate parameters according to the technical characteristics of manufacturing processes ‘and their potential impact on stability and bioavailability of the product and its packaging’.
