Risks related to Method Validation and Stability Studies

[abdou2013]

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

 

[Ajit Basrur]

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

Moved your question in this new thread in the Pharmaceutical section.

Instead of ISO 9001:2015, have you referred to ICH Q9, Quality Risk Management that is most appropriate for the Pharmaceuticals?

https://www.ich.org/fileadmin/Publi.../Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
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[v9991]

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