What are the phases of the quality risk management process?
With the aim of achieving the greatest possible safety for drug quality and supply, the QRM process (quality risk management process) starts with risk assessment, i.e. hazard identification and the analysis and evaluation of the resulting risks. Based on the results of the first phase, the risk control phase follows. The aim here is to minimise the risks up to an acceptable residual risk. The regular review of previous results and assessments completes the life cycle of the QRM process.
[GMP Compliance Adviser, 19. A]
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