Method Development and Validation

Method Validation is essential for adherence to Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). In order to meet these needs, we can assist you with method validation, method qualification and method transfer. Analytical Method Validation (AMV) is a requirement within the biopharmaceutical industry for all methods used in testing raw materials, in-process materials, final containers and excipients. In a regulated environment, it is rare for the laboratory that develops and validates a method to perform routine sample testing. Instead, once developed and validated (in the originator, or "sending" laboratory), methods commonly are transferred to another laboratory (the "receiving" laboratory) for implementation. However, the receiving laboratory must still be able to get the same results, within experimental error, as the originating laboratory. The process that establishes documented evidence that the analytical method works as well in the receiving laboratory as in the originator's laboratory, or the transferring laboratory, is called analytical method transfer (AMT). Analytic method development, validation, and transfer are key elements of any pharmaceutical development program. This technical brief will focus on development and validation activities as applied to drug products. Often considered routine, too little attention is paid to them with regards for their potential to contribute to overall developmental time and cost efficiency. These method-related activities are interrelated. They are iterative, particularly during early drug development phases. Parts of each process may occur concurrently or be refined at various phases of drug development. Changes encountered during drug development may require modifications to existing analytic methods. Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product-specific acceptance criteria and stability of results.Validation should demonstrate that the analytical procedure is suitable for its intented purpose. Design of experiment is a powerful tool for the method characterization and validation. Analytical professionals should be comfortable to use it to characterize and optimize the analytical method. An effective analytical method development and its validation can provide significant improvements in precision and a reduction in bias errors. It can further help to avoid costly and time consuming exercises.