QCP 512-Principles, Procedures and Software in Validation

The course is devoted to discuss the integrated approaches conducted for validation necessary to control and assure the quality of pharmaceuticals. It highlights the guidelines recommended by authorities (International Conference on Harmonization, ICH; Food and Drug Administration, FDA; United States Pharmacopeia, USP) for validation of analytical operations and results, analytical instrument qualification, statistical aspects of analytical methods validation, use of statistics to support validation data, exploration of statistical techniques, planning, the sources of errors and uncertainties that happen during analysis procedures and the approaches for their minimizations and practical execution of validation parameters, preparing validation protocols/reports. In addition, it describes the documentation of validation, and validation software