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Comprehensive Quality Risk Management in Materials Management

Learn about Assessment, Auditing, Supplier Agreements, and more to assess and mitigate quality risks in materials management and distribution. Ensure proper storage, logistics, and handling of materials for pharmaceutical products. Maintain infrastructure and rank risks in the supply chain.

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Comprehensive Quality Risk Management in Materials Management

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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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