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Set up Qualification (IQ): documented verification the products or techniques, as mounted or modified, adjust to the approved style and design, the producer's suggestions and/or user requirementsAny out-of-specification consequence attained ought to be investigated and documented As outlined by a procedure. This treatment should really incorporate

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Dependant on the Evaluation, determine the quantity of residue current in Just about every rinse/swab, and on The idea of rinse/swab consequence and measure probable contamination in the subsequent merchandise, calculate the amount of residue existing in Just about every products associated.Three consecutive batches shall be chosen for process qual

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