5.1 - Supplier Approval and Control 111.55 including its identity

including its identity

relevant to their needs

quality and purity is met

or stage in the manufacturing process where this is necessary to ensure its quality and that it is packaged and labelled as specified in the manufacturing record MMR

or drug products shall not be reactive

5.1 - Supplier Approval and Control 111.55 including its identityThe 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