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Q9: Quality Risk ManagementRegulatory Resource: Q9: Quality Risk Management
The tripartite harmonised ICH guideline was finalised (Step 4) in November 2005.
This guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.