Method Validation

data on screen

Our analytical network has extensive knowledge related to compliant phase-appropriate validation for clinical processes and ICH compliant validation for commercial processes. 

Our method verification or validations have been reviewed by all major regulatory bodies. Our practices are compliant with the latest regulatory guidance including ICH Q2 (R2) and Q5A (R2). Through multiple Pre-Licensing (PLA) or Pre-Approval (PAI) inspections, you can be confident our method practices are compliant with current regulatory expectations.

We have extensive experience with programs being transferred to our sites for clinical or commercial manufacturing. Our key to successful establishment of a customer’s process lies with our emphasis on transfer of methods from customers or between our sites and demonstrating that methods are fit for purpose and validated according to regulatory requirements.  

The transfer and phase-appropriate validation of analytical methods is governed by internal master plans and adherence to the following regulatory guidelines: 

  • FDA 2015 Guidance on analytical methods  
  • ICH Q2(R2)  
  • ICH Q5A (R2) 
  • ICH Q6b  

Our Method Transfer / Validation Strategies

Elements of our method transfer / validation strategies include: 

  • Harmonized core equipment at each site, and standardized practices for method transfer and validation 
  • Establishment of how well the method performs to measure specific attributes during method development. When appropriate, the stability-indicating capabilities of methods are evaluated via forced degradation studies
  • Phase-appropriate validation practices for early phase through late phase clinical manufacturing 
Scientist using a pipette to transfer liquid into a reaction tube
  • Prior to use in cGMP testing, compendial methods are verified and the performance criteria of product and process residual methods is established through evaluating the linearity, precision, system suitability, and LOQ
  • For confidence in defining Critical Process Parameters and Critical Quality Attributes, sample types are qualified before process characterization studies are performed 
  • As a program matures towards late phase development, method risk assessments are performed, and if needed, remediation studies are executed to ensure the long-term performance of the method 
  • Method robustness studies in accordance with Q14 guidelines 
  • Prior to PPQ manufacturing, we complete formal ICH method validation studies of any method to be used during process validation and conformance lot testing 


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Discuss Your Project

Contact us to learn more about our method validation services.