CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.S.5 Reference Standards

• Provide information on reference standards used for testing of drug substance Q6A, Q6B

3.2.S.6 Container Closure System

• Primary packaging components: identity of materials of construction and their specification • Non-functional secondary packaging components: only a brief description • Suitability should be discussed: e.g. protection from moisture/light, compatibility with drug substance – sorption, leaching, safety

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3.2.S.7 Stability

• Stability Summary and Conclusions: types of studies, protocols, summary results, forced degradation studies, conclusions re storage and shelf-life, re-test date Q1A, Q1B, Q5C, CHMP guideline for established DS

• Post-approval Stability Protocol & Stability Commitment: Q1A, Q5C

• Stability Data: results in appropriate format, analytical methods used, validation of analytical procedures

Q1A, Q1B, Q2A, Q2B, Q5C

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