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Navigating the Formality Spectrum in ICH Q9(R1).
- Source :
- Pharmaceutical Technology; Jul2023, Vol. 47 Issue 7, p40-49, 6p
- Publication Year :
- 2023
-
Abstract
- The article discusses the revised International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q9(R1) Quality Risk Management (QRM) guideline, which emphasizes the importance of balancing formality and practicality in risk management. It offers guidance on customizing the degree of formality in the risk management process based on the organization's needs and the level of risks involved.
- Subjects :
- HEALTH services administration
GOVERNMENT regulation
PHARMACEUTICAL technology
CHANGE management
REGULATORY approval
DRUG packaging
DOCUMENTATION
QUALITY assurance
QUALITY control
GROUP decision making
COMMUNICATION
PHARMACEUTICAL industry
DRUG development
RISK management in business
MANAGEMENT
PATIENT safety
Subjects
Details
- Language :
- English
- ISSN :
- 15432521
- Volume :
- 47
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Pharmaceutical Technology
- Publication Type :
- Periodical
- Accession number :
- 164978104