Module 9 2024

03/09/2024

CMC Drug Development Pathway

TPP Update

TPP Update

TPP (ongoing)

I

II

III

IMPD/ IND

Pre-Clinical

Clinical Development

Post Approval

MA

Pilot Scale Nonclinical pre-phase I studies (tox) Reduced Scope Forced Deg Study Characterisation of Impurities Stability Early Phase Method Validation Initial Reference Standard

GMP Batches • Forced Degradation Studies • Stability • In-use Studies • Reference Standard • E&L • Data Trending: (Process Consistency) • Process Characterisation

Marketed Drug Product • Variations:

PPQ series (PV) •

Cell line Selectio n RCB

Final Method and Process Val idations

Manufacturing process / Test Methods/ Facility

• Formal Forced Degradation • In-use Studies, Release , Stability, Characterisation • Clearance Val idation Studies • Commercial Spec Setting • Commercial Ref Standard • Licence Application (Region Specific) Support Studies • Tiered Cell banking (MCB/WCB)

Process Development, Process Lab Scale • Initial CQAs (ongoing) • Formulation development • Stability Studies / Hold Time Studies • Initial Clearance Studies • Method Development/optimisation • MCB

GMP Batch Process Consistency: Pilot vs GMP Characterisation Stability

Agency Meeting(s) Activities need to also account for any additional DS/ intermediates/ Placebo/ DP kit components/ devices/ presentations

Comparability

The Organisation for Professionals in Regulatory Affairs

5

5

Control Strategy

The Organisation for Professionals in Regulatory Affairs

6

3