Validation Documents
This is a work in progress, this article is by no means complete yet!
+IVT Network article: Method Validation (for Medical Devices) Regulatory Guidance
This is a great place to start.
+Toggle Example #1
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Guidance for Industry - Process Validation: General Principles and Practices
FDA, January 2011 - Revision 1
FDA, January 2011 - Revision 1
Process Validation - A Lifecycle Approach
Grace E. McNally, Senior policy advisor; FDA; May 6th 2011
Grace E. McNally, Senior policy advisor; FDA; May 6th 2011
Technical Report No. 60 - Process Validation: A Lifecycle Approach
PDA (Parenteral Drug Association); 2013
PDA (Parenteral Drug Association); 2013
EudraLex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 15: Qualification and Validation
EUROPEAN COMMISSION; DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY; October 1st 2015
EUROPEAN COMMISSION; DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY; October 1st 2015