What is Method Validation?
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use.
Validation is a process-risk will determine the effort.
High Risk:Total validation
Moderate Risk:Testing,Documentation
Low Risk:Testing the change
FDA Guidelines For Method Validation
Analytical Procedures and Methods Validation (Draft)
FDA - Industry Guidance Bioanalytical Method Validation
Methods Validation for Abbreviated New Drug Applications
Guideline for Submitting Samples and Analytical Data for Methods Validation
Validation of Chromatographic Methods
Other Guidelines For Method Validation
ICH - Guidance for Industry - Q2A: Text on Validation of Analytical Procedures
ICH - Guidance for Industry - Q2B: Validation of Analytical Procedures –Methodology
United States Pharmacopeia, Validation of Compendial Methods (Chapter <1225>)
United States Pharmacopeia, Verification of Compendial Methods,, (Chapter <1226>)
United States Pharmacopeia, Transfer of Analytical Procedures,, (Chapter <1224>)
What Methods to be Validated?
ICH:
Identification tests
Quantitative tests for impurities' content
Limit tests for the control of impurities
Quantitative tests of the active moiety in drug substance or drug product or other selected component(s) in the drug product.
USP:
Category 1: Like ICH 4
Category 2: Like ICH 2,3
Category 3: Performance tests like dissolution
Category 4: Like ICH 1
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
For more details visit us at:http://www.complianceonline.com/analytical-test-methods-validation-fda-ich-and-usp-requirements-webinar-training-701122-prdw?channel=slideshare-ppt
2. What is Method Validation?
• Methods validation is the process of demonstrating that analytical
procedures are suitable for their intended use.
• Validation is a process-risk will determine the effort.
High
risk
• Total validation
Moderate
risk
• Testing, documentation
Low risk
• Testing the change
3. FDA Guidelines For Method
Validation
• Analytical Procedures and Methods Validation (Draft)
• FDA - Industry Guidance Bioanalytical Method
Validation
• Methods Validation for Abbreviated New Drug
Applications
• Guideline for Submitting Samples and Analytical Data
for Methods Validation
• Validation of Chromatographic Methods
4. Other Guidelines For Method Validation
• ICH - Guidance for Industry - Q2A: Text on Validation
of Analytical Procedures
• ICH - Guidance for Industry - Q2B: Validation of
Analytical Procedures –Methodology
• United States Pharmacopeia, Validation of
Compendial Methods (Chapter <1225>)
• United States Pharmacopeia, Verification of
Compendial Methods,, (Chapter <1226>)
• United States Pharmacopeia, Transfer of Analytical
Procedures,, (Chapter <1224>)
5. What Methods to be Validated?
ICH:
• Identification tests
• Quantitative tests for impurities' content
• Limit tests for the control of impurities
• Quantitative tests of the active moiety in drug substance or
drug product or other selected component(s) in the drug
product.
USP:
• Category 1: Like ICH 4
• Category 2: Like ICH 2,3
• Category 3: Performance tests like dissolution
• Category 4: Like ICH 1
6. What Aspects to Cover?
As per ICH and USP, validation characteristics are same.
ICH USP
• Accuracy
• Precision
• Repeatability
• Intermediate precision
• Reproducibility
• Specificity
• Detection Limit
• Quantitation Limit
• Linearity
• Range
• Robustness
• Accuracy
• Precision
• Specificity
• Detection Limit
• Quantitation Limit
• Linearity
• Range
• Robustness is not part of formal
validation
7. Validation Parameters for Different
Method Tasks
Analytical Tsk Identification Impurity
Quantitative
Impurity
Qualitative
Assay
Accuracy No Yes No Yes
Precision No Yes No Yes
Specificity Yes Yes Yes Yes
Limit of
No No Yes No
Detection
Limit of
Quantitation
No Yes No No
Linearity No Yes No Yes
Range No Yes No Yes
Robustness Expected to be done during method development
8. 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
