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?

 Ans:

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

 http://www.validation.org/wp-content/uploads/2015/02/JVT2004_Risk-Management.pdf

PDA Slides:

https://www.slideshare.net/StephanOKrausePhD1/riskbased-analytical-method-validation-and-maintenance-strategies-sksep13

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

https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm313087.htm

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... :


https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf

jel@jelincoln.com