What you'll learn:
- Understand and define main principles of Analytical Method Validation by integrating Good Manufacturing Practices (GMP)
- Define general scope of pharmaceutical analysis of drug substances and drug products in pharmaceutical industry
- Understand and define main analytical method validation parameters required for analytical method validation
- Discuss Analytical Method Validation process flow by integrating GMP rules
- Understand basic elements of Analytical Method Validation Protocol and Analytical Method Validation Report
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 CONTENT
1 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
