Risks related to Method Validation and Stability Studies

#1
can any one help me to gain sop for iso9001-2015 in risks related to validation of method of analysis and stability studies of pharmaceutical product
 
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Ajit Basrur

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#3
can any one help me to gain sop for iso9001-2015 in risks related to validation of method of analysis and stability studies of pharmaceutical product
i see the risk assessment at atleast three levels,
1. system :- the sop covering the standards / requirements vs practices outlined in sop
2. process :- applying the SOP requirements to the specific product
3. any exceptions/deviation or incidents,

ICH Q9 provides broad outines for the procedure; and SOP you are looking seems to be very specific.
here's certain references., which could be usefull.

Risk Assessment and Lifecycle Management in Stability Testing

Stability Testing – Doing Everything or Doing the Right Thing?

Risk-based Analytical Method Validation and Maintenance Strategies

Analytical Risk Assessment from Validation results
 
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