1. Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT II. 5 Quality risk management as part of… Materials Management Competent Authorities Industry

2. Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2 ICH Q9 QUALITY RISK MANAGEMENT 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. Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3 ICH Q9 QUALITY RISK MANAGEMENT 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. Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4 ICH Q9 QUALITY RISK MANAGEMENT II.5: QRM as part of materials management  Storage, logistics and distribution conditions >Adequacy of arrangements to ensure maintenance of 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. Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5 ICH Q9 QUALITY RISK MANAGEMENT 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