CRED Managing Variations Effectively

Your responsibilities … ctd Apply a risk-based approach of the change on your product

Classification of variations – your responsibility – Apply the regulation to suit your knowledge of the product – Identify risky products & changes: do a risk assessment of the change on your product, consider: • Magnitude of the change, complexity, grouping, sensitivity of API/product to changes etc • What will be the impact on your product? • How likely is that impact to occur? • If the impact occurs, how serious might it be? – does it have public health concerns?

This approach works for BSVs

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