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  3. Sub-Part A: Definitions and the European Union
  5. 1.5 - Risk Assessment or QRM
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1.5 - Risk Assessment or QRM

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Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk

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GMP-SOP-Download Drug1.4 - Product Quality Review (PQR)
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GMP-SOP-Download Drug1.6 - Good Distribution Practice GDP
<Male tightrope walker in red top taking a great risk crossing a rope between two sandstone cliffs of a river canyon with a huge drop below with the sun shining on one side. Credit> 343576142 © Irina Ukrainets | Dreamstime.com
$26.00 USD
$26.00 USD