Method validation

Validation of bioanalytical methods (clinical studies)     and       method validation according to ICH Q2(R1)

 

A method validation proves that the method is suitable for its intended purpose. Method validations play a role at different times in the life cycle of pharmaceuticals. First of all there’s development, where the bioanalytical methods used for clinical studies are validated. These provide quantitative evidence of the active pharmaceutical ingredient (API) in biological (human) liquids (for example blood, urine, stool). Subsequently, the release and stability methods must be validated according to the requirements stated by the ICH Q2(R1) guideline after a transfer (for example from development to production site), if they are self-developed test procedures. Compendial methods have to be verified. Depending on the type of analysis (identity, purity – quantitatively or as limit test, potency), different parameters have to be validated. We give you advice regarding the scope of the validation work and support you in creating the necessary documentation.

 

Our services in the field of method validation include:

  • Creating SOPs for method validation as well as for each single test procedure
  • Checking if the existing documentation meets current requirements
  • Consultation regarding the extent of the validation and / or verification
  • Consultation regarding the selection of suitable contract laboratories (in the case of external outsourcing)
  • Creating the documentation for the verification of compendial methods
  • Creating (re-)validation plans
  • Data evaluation, graphical presentation and evaluation of results while creating the validation report