Verta-Life-Sciences---an-Introduction-Dec-2015-v5-9

Quality Risk Management of the drug product across the product lifecycle- Assessment, Control, Communication and Review of Risks

ICH Q9

Quality Risk Management of the drug product across the product lifecycle- Assessment, Control, Communication and Review of Risks.

Initiate Quality Risk Management Process:
  • Risk Assessment (DFM Tools: i.e. FMEA)
    • Risk Identification
    • Risk Analysis
    • Risk Evaluation
  • Risk Control
    • Risk Reduction
    • Risk Acceptance
    • Risk Evaluation
  • Risk Communication
  • Review Events
  • Output / Result of the Quality Risk Management Process
ICH Q10: Pharmaceutical Quality System

To provide a comprehensive model for an effective pharmaceutical quality system that is based on and enhances ISO quality concepts and applicable GMP regulations throughout the product lifecycle in the following areas. It applies to all stages of the product lifecycle defined as Pharmaceutical Development, Technology Transfer, Commercial Manufacturing and Product Discontinuation.

  • Process performance and product quality monitoring system
  • Corrective action and preventive action (CAPA) system
  • Change management system
  • Management review of process performance and product quality.