This course reinforces the concept of how the pharmaceutical laboratory works by focusing on method validation requirements within the pharmaceutical industry. It introduces students to the regulatory (ICH, FDA) requirements and guidelines for systems validation, including TPP-acceptable methods and GMP regulations. Validation methods that are taught include Related Substances, Assay, Dissolution and Cleaning. Critical validation parameters (e.g., linearity, specificity, limit of quantitation, etc.) are focused on as well as validation protocols including establishing specifications and dealing with exceptions or out-of-specification (OOS) results. Process validation characteristics (i.e., Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification(PQ) or System Suitability) are also emphasized as well as ‘Best Practices’ such as Process Capabilities and Annual Product Review. This course is taught at Seneca College.
