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II. 5 Quality risk management as part of…

II. 5 Quality risk management as part of…. Materials Management. Industry. Competent Authorities. II.5: QRM as part of materials management. Assessment and evaluation of suppliers and contract manufacturers To provide a comprehensive evaluation Auditing Supplier quality agreements

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II. 5 Quality risk management as part of…

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  1. II. 5 Quality risk management as part of… Materials Management Industry Competent Authorities

  2. II.5: QRM as part of materials management • Assessment and evaluation of suppliers and contract manufacturers • To provide a comprehensive evaluation • Auditing • Supplier quality agreements • Starting material • To assess differences and possible quality risks associated with variability in starting materials • Age • Route of synthesis ICH Q9

  3. II.5: QRM as part of materials management • Use of materials • Appropriate use material under quarantine • for further internal processing • Appropriateness of Reprocessing, reworking, use of returned goods ICH Q9

  4. II.5: QRM as part of materials management • Storage, logistics and distribution conditions • Adequacy of arrangements to ensure maintenanceof appropriate storage and transport conditions • Temperature • Humidity • Container design • Determine the effect on product quality of discrepancies in storage or transport conditions • Cold chain management (see other ICH guidelines) ICH Q9

  5. II.5: QRM as part of materials management • Storage, logistics and distribution conditions • Maintain infrastructure • Capacity to ensure proper shipping conditions • Interim storage • Handling of hazardous materials and controlled substances • Customs clearance • Provide information for ensuring the availability of pharmaceuticals • Ranking risks to the supply chain (e.g. Anti-Counterfeit) ICH Q9

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