New ICH Guidelines:
*ICH Q13* on Continuous Manufacturing &
*ICH Q14* on ATP – QbD (Analytical target profile and quality by design)
New ICH Guidelines: ICH Q13 on Conti Manufacturing and ICH Q14 on AQbD
In a press release from 22 June the International Council for Harmonisation (ICH) has announced that they will prepare new topics for the future. The Assembly agreed to begin working on two new topics for ICH harmonisation:
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14)
and
Continuous Manufacturing (Q13)
The long anticipated revision of ICH Q2(R1) “Guideline on Validation of Analytical Procedures: Text and Methodology” has been approved and the work plan is scheduled to commence in Q3 2018. It is intended that the new guidelines will be consistent with ICH Q8(R2), Q9, Q10, Q11 and Q12 .
The AQbD approach is very important to collect information in order…
View original post 154 more words