CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.A Appendicies

Facilities and Equipment – Biotech products

Details about manufacturing site, rooms & manufacturing flow;

Cleaning principles and further measures for preventing contaminations

Adventitious agents

Detailed information about ingredients with high risk for contamination with adventitious agents (balance with 3.2.P.4.5)

Novel excipients

Detailed description in addition to 3.2.P.4.6; safety data, if appropriate

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3.2.R Regional Information

Additional information related to the active substance or drug product specific to a region, e.g.

• Drug Product Process Validation Scheme (EU) • Certificate of Suitability (EU/ many further countries) • Executed Batch Records (US/ many further countries) • Method validation Package (US) • Comparability Protocols (US) • Declarations of no alcohol/ no pork content/ CPP…

Guidance: ICH M4Q (R1); EMA NtA Vol. 2B, national requirements

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