quality risk management
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- ICHQ10 Pharmaceutical quality system
- ICHQ11 Development and manufacture of drug substances
- ICHQ3D Guideline for elemental impurities
- Definition
- A systematic process for the assessment, control, communication, and review of risks to the quality of the drug medicinal product across the product lifecycle.
- Abbreviation for
- QRM
- Broader Term
- quality system
- risk management
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