SUPAC; Scale Up & Post Approval Changes

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PHARMA TRICKS FOR EXAMS

PHARMA TRICKS FOR EXAMS

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Scale up, and, scale down, post approval changes, categories of change, levels of change, components or composition, site of manufacture, scale up of manufacture, manufacturing process, equipment, level, changes, 1, 2, 3, I, II, III, unlikely to have detectable impact, could have significant impact, likely to have significant impact, SUPAC, supac domumentation, Annual report, AR, PAS, Prior approval supplement, CBE, changes being effected Supplement, CBES, changes to drug product,
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