Analytical methods must be validated to ensure the reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories run the method. In addition, when methods are transferred between laboratories they must be shown to be reliable. In certain circumstances, a waiver of method transfer requirements may be justified. Recent guidance on method validation and transfer has been produced by FDA and EMA. The USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures, and new ICH guidance on method development and validation is expected soon.

This training course will help you understand the regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes material to help you plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.

Course Outcomes:-

1. Understand and define main principles of Analytical Method Validation by integrating Good Manufacturing Practices (GMP)

2.Define general scope of pharmaceutical analysis of drug substances and drug products in pharmaceutical industry

3. Understand and define main analytical method validation parameters required for analytical method validation

4. Discuss Analytical Method Validation process flow by integrating GMP rules

5. Understand basic elements of Analytical Method Validation Protocol and Analytical Method Validation Report