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22nd December 2021
The European Medicines Agency has published for public consultation on the ICH harmonised guideline on Quality Risk Management Q9 (R1).
This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labelling materials in drug (medicinal) products, biological and biotechnological products).