CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.S.1 General Information

• Nomenclature (INN, non-proprietary, compendial, CAS)

• Structure (stereochemistry, biotech – schematic amino acid sequence) • General properties (physicochemical, biological activity for biotech)

• Reference: ICH Guidelines: Q6A and Q6B

The Organisation for Professionals in Regulatory Affairs

15

3.2.S.2 Manufacture

• Manufacturer(s): all sites of manufacture including testing

• Description of Manufacturing Process and Process Controls: flow diagram and narrative. Q5A, Q5B, Q6B • Control of Materials: Q6A, Q6B. Biologically sourced – details in 3.2.A.2. Cell bank – Q5A,B,C,D

• Control of Critical Steps and Intermediates: Q6A, Biotech Q6B and Q5C

• Process Validation/Evaluation: aseptic processing and sterilisation validation, justify in-process controls all cases • Manufacturing Process Development: include history of development of the drug substance NCE- Q3A, biotech - Q6B, relevant batch information on drug substance batches manufactured and their use

The Organisation for Professionals in Regulatory Affairs

16