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Important changes, for instance a new production website or variations in the level of active components, call for a lot more in depth documentation such as steadiness testing and possibly bioequivalence research.➢ Dry Granulation System: In this method, the API and excipients are compacted to variety slugs or ribbons, which are then milled into
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Ans: A deviation is undoubtedly an unexpected celebration that accrues through the continued operation/ activity/ Documentation/ entries at any phase of receipt, storage and Production, Evaluation and distribution of medication products and solutions/Intermediate/Uncooked materials/ packing elements. The deviation should be to be reported as and wh