Re-validation: When Is It Necessary
What is Re-validation? Re-validation include: Testing
SOPs
Documentation
Disaster Planning
Approvals
Training
Qualifications
Life Cycle of Analytical Methods
Change of products
Re-validation
Validation Change of analytical methods
Why Revalidate? Possible causes of analytical method change that warrant method revalidation: • Synthetic process change • Formulation change • Out-of-Specification investigation • Specificity problem (e.g., new impurity) • Ruggedness issue • Post approval changes
A Daily Question…Do I need to “Re-validate”?
Something changed, what do I need to do to be compliant? Evaluate the Changes What is the reason? What needs to get done?
Risk Assessment Is the impact of the change significant? Can it harm a person? Can it hurt the company? Is there a regulatory concern?
Plan the Effort Was it the result of a problem? Was it an update? Is it a high priority, visible project?
Want to learn more about analytical method validation, FDA requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: • ICH, FDA and USP Requirements for Method Validation • How to Validate Analytical Methods and Procedures • Validation of Analytical Methods and Procedures • Eliminate the Confusion - Analytical Method Qualification and Validation • Lifecycle Approach to Analytical Methods with QbD Elements • Analytical Instrument Qualification and System Validation • Lifecycle Approach to Analytical Methods for Drug Products