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
* Above ref is not current. For a reference to the JVT and a search feature, see:
https://www.pharmaceuticalonline.com/doc/journal-of-validation-technology-0002
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
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
* Added replacement URL for JVT, 10/13/23 - JEL
