Saturday, August 18, 2018

Method Validations

Some Q&A from a recent webinar:

Ques: Do you have any recommended references to create risk categories for method validations?


JVT Article 2004, especially note flow charts; caveat – include potential problems from normal use, not just from a failure mode:

PDA Slides:

Q8, Q9, & Q10 Questions and Answers, U.S. FDA:

U.S. FDA Guidance, 2015: Analytical Procedures and Methods Validation for Drugs and Biologics; note several of the headings may provide risk categories, e.g, Apparatus/Equipment, Operating Parameters, Reagents/Standards, Sample Preparation, Standards Control Solution Preparation, Procedure, System Suitability, Calculations, Data Reporting... :