CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.7 Container Closure System

➢ Quality description of primary packaging materials, functional secondary packaging components and dosing devices: • Specification applied by the finished product manufacturer (Description, identity, attributes relevant for protecting the drug product) • Detailed documentation (drawings, if applicable), including compliance declarations for plastics

➢ Brief description of non-functional secondary packaging components

NB: Suitability information should be placed in 3.2.P.2

Guidance: EMA „Plastic Immediate Packaging materials“, Pharmacopoeias

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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3.2.P.8 Stability

Stability Summary and Conclusions

Description/ explanation of study(-ies) & design(s) - bracketing, matrixing, in use…. Summary of results and conclusions for shelf-life, general and in-use storage conditions

Post-Approval Stability Protocol and Commitments

Continuation of running studies/ start of new ones in case of quality changes

Stability data

Tabulated study results (highlight OOS values); information about test procedures, if different from 3.2.P.5.2

Guidance: ICH Q1 series, EMA scientific guidelines on stability

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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