CRED Managing Variations Effectively

Type IA strategy (2): prior implementation What does implementation mean?  Quality changes: company makes change to its Quality System • eg Type IA IN change in flavouring system  Company manufactures conformance batches  Generate stability data: 2 batches (3 months)  Implement changes in internal Quality System  Internally approves the revised product information  Submit Type IA IN notification (immediately) Type IA (in) What does immediate mean?  Generally within 2 weeks of implementation  implementation date must be a past (historical date) Except when the Type IA IN is dependent on a Type IB/II  Submit grouped variation and implement on approval Type IA (annual) : notify within 12 months

Implementation date is in the past but can be a future date if dependent on a Type IB/II (CMDh Q&A 5.3)

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