METHOD DEVELOPMENT AND VALIDATION
- Analytical method development and validation is a crucial components of any pharmaceutical development program using suitable technique for the qualitative and quantitative estimation through the establishment of product specification and its shelf life.
- It is critical in the development of new methods that the analytes of interest be clearly identifiable prior to performing a validation study. The new methodology must be capable of not only observing the analytes in question, but that they are quantifiable, and not obstructed by other components in the matrix. The Study Team at CATTS LABS work with our customers to determine the best technique for analysis (given a full understanding of the manufacturing process, the matrix, and what could potentially be present). Our extensive knowledge in this field helps us to design a testing protocol that will be scientifically defensible when our clients submit their product for approval to the regulatory agencies. The laboratory will develop methods capable of detecting these analytes using the most appropriate sample preparation and analysis techniques. When a suitable method has been defined, a protocol will be provided and the method evaluated in compliance with regulatory guidelines.
- Validated methods establish clear limitations of application by verifying the process is robust enough so that the slight variations between operators or between laboratories do not have an impact on results