method validation

method validation

The process of proving that an analytical procedure is effective for its intended use.
References in periodicals archive ?
It can be easy to dismiss an emphasis on method validation in a CLS curriculum for entry-level positions because it is often viewed as a skill that is only needed by the experienced CLS.
For these reasons, production of plasma or serum reference materials that have Pb concentrations certified close to current human values is urgently needed to support method validation.
In addition, its pharmaceutical research and development services include preformulation studies, formulation development, process development, analytical development, and method validation.
Issues such as method validation, variability and measurement uncertainty need to be treated carefully in certain circumstances; for example, in legal or forensic contexts.
Empower software extends beyond traditional chromatography to include integrated applications such as dissolution, method validation, integrated chemical structures, and polymer analysis.
However, lack of a seaweed standard for method validation and quality control in analytical measurements limits the reliability of the current analytical results and the data comparability among national and international laboratories.
Food and Drug Administration (FDA) Guidance for Industry on Bioanalytical Method Validation and according to the International Conference on Harmonization Guidelines on Validation of Analytical Procedures.
Milestone-based option periods include completion of a Phase 1b clinical study, a Phase 2 clinical study and non-clinical efficacy studies as well as manufacturing technology transfer and optimization, process and analytical method validation and consistency lot manufacture.
Intertek s integrated formulation and analytical teams carry out analytical development, method validation, formulation support, stability testing, extractables / leachables and GMP commercial release testing with specialist expertise for both small and large molecules and also inhalation technologies.
Additional products offered include Assayed Procalcitonin Daily Quality Control Materials and Procalcitonion Method Validation kits.
Wong believes that "multiuse facilities overseas can expect continued scrutiny of their cleaning validation program," and that "analytical method validation will continue to be a sore point with overseas developers seeking to come to the U.
After introducing analytical method validation in general, they discuss analytical instrument qualification, high-performance liquid chromatography method development and optimization with validation in mind, method validation basics, robustness and system suitability, setting specifications and investigating out-of-specification results, validation by type of method, analytical method transfer, and implementing new technology in a regulated environment.