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What is Quality Risk Management in Pharmaceuticals about?

Quality Risk Management (QRM) is a systematic process for assessing, controlling, and reviewing risks to quality. It can be applied proactively during development and manufacturing or retrospectively. The QRM process ensures risk evaluations are scientifically based and linked to patient protection. It also ensures the level of effort, formality, and documentation is commensurate with the level of risk. An effective QRM approach can ensure high drug quality by proactively identifying potential issues. It al

Author

Dian Novitasari

Language

EN