CRED Managing Variations Effectively

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Acceptable grouping ??? Possible answers: Yes No Not sure/grey area

 Manufacturing site changes : • addition of FP manufacturer

: Type IB • addition of primary packaging site : Type IA In • addition of secondary packaging site : Type IA In

 Manufacturing process changes :

• change to method of manufacture : Type IB • increase in batch size : Type IA • change to in-process controls x2 : Type IB • addition of new test and limits x2 : Type IA - bulk product

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