CRED Managing Variations Effectively

 Acceptable grouping ??? “To update the packaging particulars of the active substance and finished product” Answer: Yes No Not sure/grey area

 Change in qualitative/quantitative composition of immediate packaging of the active substance  Deletion of non-significant specification parameter of immediate packaging of active substance  Change in qualitative/quantitative composition of immediate packaging of the finished product  Change in pack size of the finished product (outside the currently approved range

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