Friday 9 October 2015

Revised Annex 17 on the Real Time Release Testing

Consultation has begun on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing.

In terms of the scope of the document:

“This document is intended to outline the requirements for application of a Real Time Release Testing (RTRT) approach in manufacturing, where the control of critical parameters and relevant material attributes may be used as an alternative to routine finished product testing of medicinal products. The main aim of the changes to this guideline is to incorporate the application of RTRT to any stage in the manufacturing process and to any type of finished products, including active substances and intermediates.”

The consultation runs until December 11, 2015.

For more details see the European Commission

Posted by Tim Sandle

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