Sub-Part E - Control of Materials

5.1 - Supplier Approval and Control

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The selection, qualification, approval and maintenance of suppliers of materials, together with their purchase and acceptance, must be documented as part of the QMS. The level of supervision must be proportional to the risk posed by the individual materials, taking into account of their source, manufacturing process, supply chain complexity and the final use. 

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Pharmaceutical tablets in blisters and supplier approved packaging and leaflets