The Art of the Analytical Method

Common Pitfalls & Approaches to the Analytical Method

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.

You’ve Selected Only One Reagent Vendor Or Kit

Having a larger pool of reagents and kits from different vendors allows for a more nimble and robust method.

You Only Have One Analyst Who Can Run The Assay Adequately

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.

You Feel That Performing Reagent Qualification is Unnecessary

Appropriate lot-to-lot qualification of critical reagents can mitigate variability of a method.

You Feel That Product-Specific Reference Material is Unnecessary

Incorporating product-specific reference material or sample is critical in confirming the suitability of the test method for its intended purpose.

You’ve Set a Generic Acceptance Criteria

Wide or inaccurate sample acceptance criteria often result in obtaining inaccurate sample results.

 problems and pitfalls in method development and validation infographic

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.