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 to get an understanding and control of sources of variability of the analytical procedure by defining the control strategy.

Based on the Analytical Target Profile (ATP) the objective of the test and the quality parameters can be defined. By performing the validation (qualification) in the QbD concept, sufficient confidence can be achieved in order to consistently generate the analytical results that meet the ATP requirements.

So far there has been a lack of an Analytical Development Guideline, which the new ICH Development Guideline is supposed to compensate. Currently analytical procedures are mainly validated according to the classical validation parameters and  these procedures mainly focus on HPLC Methods. Therefore this ICH topic has a top priority for the pharmaceutical industry. It is expected that the Revision of the Q2 (R1) Guideline will help to implement new and innovative analytical methods.

For more details please read the complete ICH Press Release (Kobe, Japan, June 2018).