Wednesday, 12 September 2018

New ICH Guidelines Q13 & Q14

The ICH Assembly agreed to begin work on two new Q topics for ICH harmonisation. These are:

Continuous manufacturing (Q13).
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14).

Work will now begin on developing formal concept papers and work plans. See:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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