5. Challenges

To succeed development and validation of a method, a total approach is recommended. A common challenge encountered during methods development and validation is that methods are generally developed by the research and development department while validation is generally the responsibility of a quality assurance and quality control. It is important that all the groups work as one staff. The transfer of analytical methods from one group to another so becomes an important step for ensuring that the proper validation is in place to justify its intended use. In order that the method will be run by several groups during its progress from development to validation, it must be robust. A shared weakness in development and validation of methods is that the methods are not robust quite. If robustness is not built into methods early in development then the results are likely to lack efficiency in quality testing and encounter lengthy and complicated validation process. The design and execution of the studies requires thorough knowledge of the product being tested as well as a good understanding of the analysis technique. New regulatory guidelines are being published that govern the expectations of regulatory agencies throughout the world for methods development and validation. There is need to meet current regulatory standards. From a simple method improvement to a complete redevelopment and subsequent implementation is tedious task. For this reason, one must be alert to current trends in regulatory guidelines and to adopt a proactive approach to changes that may affect development and validation programs. Finally, one of the key requirements for methods validation is that only well-characterized reference materials with proper documented purities should be used during method validation.