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Method Validation

As your research partner, BioReliance can assist you with method validation, method qualification, and method transfer applications. Analytical method validation (AMV) is a requirement within the biopharmaceutical industry for all methods used in testing:

  • Raw materials
  • In-process materials
  • Final containers
  • Excipients
  •  

Method validation is essential for adherence to Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) regulations.


BioReliance CRO scientists have extensive experience in analytical methods and processes and will help you with all aspects of your method validation process, whether you need to develop assay methods from scratch or transfer, optimize, and validate an existing assay.

 

Learn more - Contact a BioReliance analytical services expert with method validation questions.

 


What are the differences between method validation, method qualification, and method transfer?

Method Validation - is used to confirm that the analytical procedure employed for a specific test is suitable for its intended use and is required for complete compliance with cGMP and GLP regulations, US FDA and international regulatory guidelines.

 

Some test method validation characteristics include:

  • Optimization and discovery are largely completed prior to method validation studies
  • Prior to validation testing, method performance is defined
  • Requirements must be met by every validation trial run
  • A method can fail validation - must be resolved for full method validation
  •  

 

Method Qualification - During early-stage pharmaceutical development, it may be acceptable to qualify methods used for product characterization or comparability studies, though these distinctions are not always clear and BioReliance recommends consultation for your specific project.

 

Some method qualification characteristics include:

  • Little to no predetermined performance expectations of method
  • Used to determine method performance elements such as specificity, linearity, accuracy and precision - for an intended application
  • A method cannot fail qualification - optimize until achieves defined performance levels or reject


 

Method Transfer - can occur between laboratories and sites, and must maintain their validated state to ensure consistent results between laboratories.

 

Method transfer options include:

  • Design of a method transfer plan
  • Defining transfer tests and acceptance criteria
  • Training of any relevant receiving personnel
  • Execution of method validation tests and analysis in regulatory compliant laboratories
  • Preparation of all method transfer documentation
  •  

 

BioReliance can help you design a regulatory compliant strategy for your method transfer needs - contact us for a consultation with one of our experienced analytical scientists.

 

When does method validation need to be performed?

 

Situations that require analytical method validation or revalidation include:

  • Method transfer to different laboratory
  • Validation prior to initial use of method in ongoing or routine testing
  • Validation upon any changes to previously-validated conditions or method parameters, if changes extend beyond scope intended by original method
  • Method is part of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission

 

What method validation services does BioReliance offer?

Examples of BioReliance method validation services include but are not limited to:

  • Literature review
  • Establishment of the intended use of the method and its performance requirements
  • Development of a validation protocol
  • QC and QA compliant execution of assays
  • QC all data
  • Optimize and finalize the test method

 

While each project will be customized to your specific method validation needs, typical method validation parameters include:

  • Specificity
  • Selectivity
  • Precision
  • Intermediate precision
  • Reproducibility
  • Accuracy
  • Trueness
  • Bias
  • Linearity
  • Range
  • Limit of detection
  • Limit of quantitation
  • Robustness
  • Ruggedness

 

U.S. and international regulatory requirements for method validation and method qualification can lack clarity, but the process is essential to development of a biopharmaceutical product.

 

BioReliance has performed numerous method validation, method qualification, and method transfer services and can help guide you from design through completion. Contact us to learn more.