EU GMP Annex 17 ‘real time testing’

The EMA has published responses to the public consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release testing.

The draft expands the concepts of ‘real time’ testing beyond just parametric release and could provide opportunities for the use of new and future technology to improve on-going process control, overall product quality and patient safety.

Such monitoring based on:

Critical Process Parameters: A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality [ICH Q8 (R2)].

Critical Quality Attributes: A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. [ICH Q8 (R2)]

These comments can be found on the EMA website.

Posted by Dr. Tim Sandle