• <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
    343576142 © Irina Ukrainets | Dreamstime.com
  • <Body and arm of a man, wearing a white shirt, sat at a wooden table on which four wooden blocks are stacked to spell Risk where the S is almost falling, and his finger is on a red arrow pointing downwards to minimize risk. Credit> AdobeStock_270610352
    AdobeStock_270610352
  • <Hand with marker pen writing on frosted safety glass the four stages of Risk Management, identify, assess, control, and monitor or review with a tick in a box against each. Credit> 52721976 © Tameek | Dreamstime.com
    52721976 © Tameek | Dreamstime.com
  • <Three hands holding up a red line on a graph representing quality which goes down after non conformances are discovered in an audit, steadies whilst assessed, then goes up again once mitigated. Credit> AdobeStock_165959885
    AdobeStock_165959885
  • <Hand with a marker pen writing Risk Management in red in a bubble in the centre of a clear screen, with arrows in black pointing to the four stages, identify, assess, control, and review the risk. Credit> AdobeStock_173501135
    AdobeStock_173501135
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<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
<Body and arm of a man, wearing a white shirt, sat at a wooden table on which four wooden blocks are stacked to spell Risk where the S is almost falling, and his finger is on a red arrow pointing downwards to minimize risk. Credit> AdobeStock_270610352
<Hand with marker pen writing on frosted safety glass the four stages of Risk Management, identify, assess, control, and monitor or review with a tick in a box against each. Credit> 52721976 © Tameek | Dreamstime.com
<Three hands holding up a red line on a graph representing quality which goes down after non conformances are discovered in an audit, steadies whilst assessed, then goes up again once mitigated. Credit> AdobeStock_165959885
<Hand with a marker pen writing Risk Management in red in a bubble in the centre of a clear screen, with arrows in black pointing to the four stages, identify, assess, control, and review the risk. Credit> AdobeStock_173501135

GMPSOPDownload Drug

1.5 - Risk Assessment or QRM

£19.99 GBP
£19.99 GBP
Tax included.

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

&lt;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&gt; 343576142 © Irina Ukrainets | Dreamstime.com
&lt;Body and arm of a man, wearing a white shirt, sat at a wooden table on which four wooden blocks are stacked to spell Risk where the S is almost falling, and his finger is on a red arrow pointing downwards to minimize risk. Credit&gt; AdobeStock_270610352
&lt;Hand with marker pen writing on frosted safety glass the four stages of Risk Management, identify, assess, control, and monitor or review with a tick in a box against each. Credit&gt; 52721976 © Tameek | Dreamstime.com
&lt;Three hands holding up a red line on a graph representing quality which goes down after non conformances are discovered in an audit, steadies whilst assessed, then goes up again once mitigated. Credit&gt; AdobeStock_165959885
&lt;Hand with a marker pen writing Risk Management in red in a bubble in the centre of a clear screen, with arrows in black pointing to the four stages, identify, assess, control, and review the risk. Credit&gt; AdobeStock_173501135