Deviations, incidents or investigations – whatever you call them – require an efficient and effective system for review and approval. The ease of the review and approval steps, and your ability to feedback weaknesses in the report, will come down to the foundational systems you have in place for consistency. Fundamentally, deviations need to meet the requirements of U.S. FDA 21 CFR 211.100 and EU GMP 5.15, 1.8 (vii) and 1.4 (xiv).

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