Description
Analytical methods must be developed and validated to ensure the quality of active pharmaceutical ingredients (APIs) and finished drug products for the intended use. Analytical method development and validation studies are required for marketing application and life cycle management of products. International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) publish the documents/guidelines which clearly outline the requirements about analytical method development and validation. In this Analytical Method Validation course, pharmaceutical analysis methods, analytical method validation paramaters, GMP requirements about analytical method validation and analytical method validation process flow have been discussed. COURSE CONTENT1 INTRODUCTION 2 ANALYTICAL TEST METHODS IN PHARMACEUTICAL INDUSTRY 2 1 Introduction to Analytical Test Methods 2 2 Categories of Analytical Test Methods 3 ANALYTICAL TEST METHODS for DRUG SUBSTANCES 3 1 Description 3 2 Identification 3 3 Assay 3 4 Impurities 4 ANALYTICAL TEST METHODS for DRUG PRODUCTS 4 1 Description 4 2 Identification 4 3 Assay & Content Uniformity 4 4 Impurities 5 ICH GUIDELINE SCOPE for ANALYTICAL TEST METHOD 6 INTRODUCTION TO ANALYTICAL METHOD VALIDATION 6 1 Types of Analytical Methods to be Validated 6 2 Analytical Method Validation Parameters 6 3 Definitions for Analytical Method Validation 7 ANALYTICAL METHOD VALIDATION PARAMETERS 7 1 Specificity 7 2 Accuracy 7 3 Precision 7 4 Precision & Repeatability 7 5 Precision & Intermediate Precision 7 6 Precision & Reproducibility 7 7 Summary for Precision 7 8 Detection Limit & Quantitation Limit 7 9 Linearity & Range 7 10 Robustness 8 ANALYTICAL METHOD VALIDATION STEPS 9 CONCLUSION
