ICH Q2 Q14 和 ICH Q6 在制定控制策略中的作用.pdf

1、Role of ICH Q2/Q14 and ICH Q6 on establishment of control strategy CMC Strategy Forum Japan 2024Dec 10thHiroko Shibata,PhD.Division of Biological Chemistry and Biologicals,National Institute of Health SciencesDisclaimer:The view and opinions expressed in the following presentation are those of the i

2、ndividual presenter,and should not be attributed to the organization with which the presenter is affiliated.1Overview of Q2/Q14 Analytical Procedure Development and Validation of Analytical ProcedureRole of ICH Q2/Q14 and ICH Q6 on Establishment of Control Strategy Future ProspectsOutline2Overview o

3、f Q2/Q14 Analytical Procedure Development and Validation of Analytical Procedure3Overview of ICH Q2/14:Scope4This guideline applies to analytical procedures used for release and stability testing of commercial drug substances and products.The guideline can also be applied to other analytical procedu

4、res used as part of the control strategy(ICH Q10 Pharmaceutical Quality System)following a risk-based approach.The scientific principles described in this guideline can be applied in a phase-appropriate manner to analytical procedures used during clinical development.Test procedures in a specificati

5、on are within the scope.There are no limitations on the types of drugs covered by the scope.Overview of ICH Q2/14:The Analytical Procedure Lifecycle5Covered by Q14Covered by Q2Q14 Main Text,Figure 1Overview of ICH Q2(R2):Validation Study Design and Evaluation6Utilization of prior knowledge including

6、 development or validation data Conducting necessary validation tests(experiments)and/or evaluating existing dataOverview of ICH Q14:Minimal vs Enhanced ApproachIdentifying attributes that need to be testedSelecting appropriate technology and related instrumentsConducting appropriate development stu