CRED Getting the CMC Dossier Right 2024

29/08/2024

General hints & tips

Interactions with CA

GMP

● Seek SA (formal/informal) – and follow it or justify! ● Local procedures – E.g. UK: national timetable, EAGs/CHM ● Response strategy ● Dedicated team for application – Consider availability when agreeing timetables/submitting ● assessors are human - they may make mistakes and they may disagree with each other – dare to disagree with them (why? justification?)

● Supply chain

– All sites audited? – Time since last audit? ● Validity of CEPs and revisions

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Final thoughts

“ Quality is never an accident. It is always the result of intelligent effort. There must be the will to produce a superior thing .”

John Ruskin (1819 – 1900)

Quality by Design: QbD!

Joseph Juran (1992)

“ In God we trust. All others must bring data! .”

Professor W. Edwards Deming, statistician

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