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.
Why should you attend: Are you confused with the terminology used for method qualification (verification/transfer/validation)? Have you received a 483 for not adequately qualifying a compendial method or are you at risk to receive one? Are you interested in knowing more about method verification? If you answered yes to any of the above questions or would simply like confirmation of your current approach to analytical method verification, then this webinar is for you.
Areas Covered in the Session: - Introduction to USP Chapter <1226> Verification of Compendial Procedures
- Why verification can be more difficult than method transfer
- Determining appropriate analytical performance characteristics and setting realistic acceptance criteria
- Protocol and report
- Follow along with an example using a USP monograph.
