Regulatory Focus™ > News Articles > New EMA Guideline on Real Time Release Testing

New EMA Guideline on Real Time Release Testing

Posted 13 April 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a final guideline on real time release testing (RTRT), aiming to provide better guidance for regulatory professionals to ensure their products consistently meet necessary specifications.

"RTRT is a system of release that gives 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," explained EMA in the guideline.

"RTRT recognizes that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end product testing and the context as such be an integral part of the control strategy."

The 13 April guidance, Guideline on Real Time Release Testing, changes the name of an earlier guideline known as Guideline on Parametric Release, and comes into effect 1 October 2012.

The scientific guideline elucidates the various considerations that go into RTRT, including the general advantages of the process, requirements to implement RTRT, its use as part of a control strategy, RTRT's application to the process, its use with biological and biotechnological products, retesting procedures, documentation, sterilization and general procedures.


Read more:

EMA - Guideline on Real Time Release Testing

Overview of comments received on 'Draft Guideline on Real Time Release Testing


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