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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 For more details visit us at:http://www.complianceonline.com/analytical-test-methods-validation-fda-ich-and-usp-requirements-webinar-training-701122-prdw?channel=slideserve-ppt

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Presentation Transcript
what is method validation
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.
fda guidelines for method validation
FDA Guidelines For MethodValidation
  • 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
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
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
what aspects to cover
What Aspects to Cover?

As per ICH and USP, validation characteristics are same.

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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 QbDElements
  • Analytical Instrument Qualification and System Validation
  • Lifecycle Approach to Analytical Methods for Drug Products