Quality In Pharma Industry : Analytical Method Validation

GMP, Quality Assurance, Validation, Drug Analysis, Drug Control, IPC Tests, QC Tests

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

Requirements

Require mobile/tablet/laptop/personal computer with internet

To be student, graduate and/or chemistry/pharma professional

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

Overview

Section 1: INTRODUCTION

Lecture 1 Introduction

Section 2: ANALYTICAL TEST METHODS IN PHARMACEUTICAL INDUSTRY

Lecture 2 Introduction to Analytical Test Methods

Lecture 3 Categories of Analytical Test Methods

Section 3: ANALYTICAL TEST METHODS for DRUG SUBSTANCES

Lecture 4 Description

Lecture 5 Identification

Lecture 6 Assay

Lecture 7 Impurities

Section 4: ANALYTICAL TEST METHODS for DRUG PRODUCTS

Lecture 8 Description

Lecture 9 Identification

Lecture 10 Assay & Content Uniformity

Lecture 11 Impurities

Section 5: ICH GUIDELINE SCOPE for ANALYTICAL TEST METHOD

Lecture 12 ICH Guideline Scope for Analytical Test Method

Section 6: INTRODUCTION TO ANALYTICAL METHOD VALIDATION

Lecture 13 Types of Analytical Methods to be Validated

Lecture 14 Analytical Method Validation Parameters

Section 7: ANALYTICAL METHOD VALIDATION PARAMETERS - SPECIFICITY

Lecture 15 Specificity-1

Lecture 16 Specificity-2

Section 8: ANALYTICAL METHOD VALIDATION PARAMETERS-ACCURACY

Lecture 17 Accuracy-1

Lecture 18 Accuracy-2

Lecture 19 Accuracy-3

Section 9: ANALYTICAL METHOD VALIDATION PARAMETERS-PRECISION

Lecture 20 Precision

Lecture 21 Precision & Repeatability

Lecture 22 Precision & Intermediate Precision

Lecture 23 Precision & Reproducibility

Lecture 24 Summary for Precision, Repeatability, Intermediate Precision and Reproducibility

Section 10: ANALYTICAL METHOD VALIDATION PARAMETERS - DEDECTION LIMIT & QUANTITION LIMIT

Lecture 25 Detection Limit & Quantitation Limit

Section 11: ANALYTICAL METHOD VALIDATION PARAMETERS - LINEARITY & RANGE

Lecture 26 Linearity & Range

Section 12: ANALYTICAL METHOD VALIDATION PARAMETERS - ROBUSTNESS

Lecture 27 Robustness

Section 13: ANALYTICAL METHOD VALIDATION STEPS

Lecture 28 Analytical Method Validation Steps

Section 14: CONCLUSION

Lecture 29 Conclusion

Anyone who is looking to learn Analytical Method Validation (AMV),Anyone who wants to learn the requirements / parameters of Analytical Method Validation (AMV),Anyone who wants to be qualified for analytical chemistry, instrumental analysis and pharmaceutical industry