Method Qualification

Evidence your testing methods are suitable for their intended use

Method Qualification is the documentation that your analytical method yields results with the required accuracy and precision.   While this type of ‘method’ doesn’t produce a physical product, it is considered a type of process qualification and falls within the scope of validation.  


  • Validation Project Management
  • Validation Plan Development and Execution
  • Change Control Documentation
  • Risk Assessment & Mitigation
  • Requirements (URS) Development 
  • Validation Issue Resolution 
  • Validation Report Development
  • Method SOP Development
  • Method Training 

Method Examples

  • Cromatograph Analysis
  • Dissolution


In Process test equipment

  • Tablet hardness
  • Loss on drying (LOD)
  • Dissolution 
  • Disintegration



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