What is Validation? Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use-Guidance for Industry Validation is a process-risk will determine the effort High Risk:Total validation Moderate Risk:Testing,Documentation Low Risk:Testing the change Validation of Analytical Methods-Key Steps Preparation Experimentation Transfering Method Documentation Step 1- Preparation Develop validation project plan Define purpose/scope of method (performance criteria) Define and verify performance of equipment Qualify/validate materials Qualify/train operator Step 2- Experimentation Perform validation experiments- may have to change either equipment or limits Develop SOPs for executing the method in routine Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks Define change control procedure Document validation experiments and results Step 3- Transferring Methods to RoutineLaboratories Designate project owner Develop procedure on how to use method Develop system suitability tests (test procedure, frequency, acceptance criteria) Define transfer tests and acceptance criteria in the routine Train routine lab analyst in development lab Repeat 2 critical method validation tests in routine lab Analyze at least three samples in development and routine lab Analyst in routine lab should give frequent feedback Step 4- Documentation for the FDA Validation report and supporting documentation: Objective, scope Methodology Materials Equipment Validation data Supporting documentation (chromatograms, spectra) Transfer to routine protocol Reference to SOP Want to learn more about analytical method validation, FDA and ICH 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 For more details:http://www.complianceonline.com/validation-of-analytical-methods-and-procedures-webinar-training-701615-prdw?channel=valppt

1. A Step-by-Step Guide for Method
Validation

2. What is Validation?
• Methods validation is the process of demonstrating that analytical procedures are
suitable for their intended use‐Guidance for Industry
• Validation is a process-risk will determine the effort
High Risk
• Total validation
Moderate
risk
• Testing, documentation
Low risk
• Testing the change

3. Validation of Analytical Methods-Key
Steps
Preparation
Experimentation
Transferring method
Documentation

4. Step 1- Preparation
• Develop validation project plan
• Define purpose/scope of method (performance
criteria)
• Define and verify performance of equipment
• Qualify/validate materials
• Qualify/train operator

5. Step 2- Experimentation
• Perform validation experiments- may have to change
either equipment or limits
• Develop SOPs for executing the method in routine
• Define type and frequency of system suitability tests
and/or analytical quality control (AQC) checks
• Define change control procedure
• Document validation experiments and results

6. Step 3- Transferring Methods to Routine
Laboratories
• Designate project owner
• Develop procedure on how to use method
• Develop system suitability tests (test procedure, frequency,
acceptance criteria)
• Define transfer tests and acceptance criteria in the routine
• Train routine lab analyst in development lab
• Repeat 2 critical method validation tests in routine lab
• Analyze at least three samples in development and routine lab
• Analyst in routine lab should give frequent feedback

7. Step 4- Documentation for the FDA
Validation report and supporting documentation:
• Objective, scope
• Methodology
• Materials
• Equipment
• Validation data
• Supporting documentation (chromatograms, spectra)
• Transfer to routine protocol
• Reference to SOP

8. Want to learn more about analytical method validation, FDA
and ICH 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