Industry news

EMA Concept Papers on revision of EU GMP Annexes 15 & 17

The EMA has published Concept Papers on the revision of EU GMP Annexes 15 & 17. The consultation period for each is until 28 February 2013.

Annex 15 is being revised to take account of ICH Q8, 9 & 10 as well as technological changes since the current version was published in 2001. The QWP published a draft revision of the Note for Guidance (NfG) on Process Validation in March 2012. The Concept Paper states that the text of other regulatory authorities’ guidance on the subject of process validation (e.g. FDA & WHO) will also be considered in the interests of harmonisation. The timeline proposed in the concept paper envisages a draft revision being published in December 2013.

Annex 17 is being revised to take account of ICH Q8, 9, 10 & 11. It is expected that a revised annex will extend the scope of what has previously been called “Parametric Release” to cover all types of medicinal products and the change its name to “Real Time Release”, which will harmonise with the QWP Guideline of Real Time Release Testing (RTRT) that was published in March 2012. Again the timeline proposed in the concept paper envisages a draft revision being published in December 2013.