Verification of Pharmacopeia Methods - Webinar by GlobalCompliancePanel

9 September 2010, United States

Introduction

Laboratories that work in a GMP environment are required to have documentation to show they are qualified to run specific, consistent and reliable analytical test methods. Method qualification of a method can be achieved in three ways: Validation, Verification (Compendial Methods) and Method Transfer (company methods). Lack of such documentation can result in warning letters from both the FDA and Health Canada. This webinar explains the reason and purpose of USP chapter<1226> and helps you to interpret what is required for verification of pharmacopeia methods to satisfy regulatory requirements. It discusses how to select appropriate analytical performance characteristics and acceptance criteria and summarizes documentation requirements of the verification process. The verification process is clarified with a step by step guide with reference to a USP monograph for an API.