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Analytical Methods: What, When and How to Validate

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Analytical Methods: What, When and How to Validate

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  1. Analytical Methods: What, When and How to Validate

  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.

  3. 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

  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.

  7. Validation Parameters for Different Method Tasks

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

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