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.
Posted by Tim Sandle
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