CRED Managing Variations Effectively

BSV information and data requirements

• Details of non-conformance / non-compliance / deviations • Investigations and corrective measures • Batch details eg BN, number or units/packs, COA, • Information on supply and demand in the UK • Prescription volumes/ burn rate eg • Whether this is an actual or potential out of stock situation • If urgent / expedited, provide evidence of discussion with DH – explain public health impact, – availability of alternative medicines

https://medregs.blog.gov.uk/2017/02/09/when-the-unexpected-happens-batch-specific-variations/

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Module 2 QOS: Risk assessment – any impact on QSE