CRED Managing Variations Effectively

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Acceptable grouping ??? Ask the audience Possible answers: Yes No Not sure/grey area  Manufacturing site and process changes : • addition of FP manufacturer

: Type IB • addition of primary & secondary packaging site : Type IA In • Increase in batch size : Type IA • Change to method of manufacture :Type IB

 Finished product specification changes : • change to assay method by HPLC

: Type IB : Type IB : Type IA

• change to impurities test

• change to dissolution test by UV (PhEur)

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