CRED Getting the CMC Dossier Right 2024

28/08/2024

Setting specification for dissolution in solid oral IR dosage forms: 3.2.P.5 Control of Drug Product • Reflection Paper on the dissolution specification for generic solid oral immediate release products with systemic action

• Dissolution of DP/test biobatch (generic) in QC dissolution method

CASE STUDY

Generic Film coated tablet 3 strengths (10, 20 & 40 mg). Test biobatch

Dissolution biobatch in QC method

Specification limit dissolution (Q) NLT 80% in 30 min

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

29

3.2.P.7 Container Closure System

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

30