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Last but not least, if third parties are actually involved in the development and qualification of analytical methods, a perfectly-created technological transfer and suitable documentation are needed for retaining the qualification position following the transfer in the method and to help the validation readiness assessment exercising in advance of

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Ans: A deviation is definitely an unanticipated event that accrues for the duration of the continuing operation/ exercise/ Documentation/ entries at any phase of receipt, storage and Production, Assessment and distribution of drugs products and solutions/Intermediate/Uncooked materials/ packing products. The deviation is always to be reported as an

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