Analytical Method Validation

About the Course

This training module on Analytical Method Validation (AMV) provides a clear understanding of analytical methods, their validation requirements, and regulatory expectations. It covers key validation parameters such as specificity, accuracy, precision, and robustness, while comparing guidance from ICH, WHO, and Schedule M. The module also addresses revalidation needs, pharmacopeial methods, common challenges, and regulatory observations, offering practical insights for ensuring compliance in quality control laboratories.

Content

• Analytical Method Validation
  • Introduction to AMV
  • What are analytical methods?
  • Why and when is validation required?
  • Challenges with validations
  • Types of analytical methods
• Key Validation Parameters
  • Validation Process
  • Specificity, Linearity, Range
  • Accuracy and Precision
  • Limit of Detection, and Limit of Quantification
  • Robustness
  • System Suitability Testing
  • Comparison between ICH, WHO, and Schedule M requirements
• Revalidation and Regulatory Compliance
  • Schedule M requirements
  • Revalidation
  • Pharmacopeial methods
  • Regulatory observations
  • Auditing quality control laboratories

Summary and Conclusion: Importance of analytical method validation in QC testing

Final Evaluation: 3 attempts to achieve the passing score in the evaluation