Poor or inadequate method development and validation can delay product approval and commercialization. Let’s examine some common problems and pitfalls that are encountered in method development and validation.
Having a larger pool of reagents and kits from different vendors allows for a more nimble and robust method.
Unlocking underlying method issues is looking at analyst variability. Move away from the “golden child” methodology and develop methods that can be performed by multiple analysts; achieving similar results.
Appropriate lot-to-lot qualification of critical reagents can mitigate variability of a method.
Incorporating product-specific reference material or sample is critical in confirming the suitability of the test method for its intended purpose.
Wide or inaccurate sample acceptance criteria often result in obtaining inaccurate sample results.
This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.