Annex II: Potential Applications

ICH Q9 QUALITY RISK MANAGEMENT

II. 5 Quality risk management as part of…

Industry

Materials Competent
Authorities

Management

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
Annex II: Potential Applications
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Annex II: Potential Applications
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
Annex II: Potential Applications
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4
Annex II: Potential Applications
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5