Steps in validating research instruments
This proposed procedure assumes that the instrument has been selected and the method has been developed.
It meets criteria such as ease of use; ability to be automated and to be controlled by computer systems; costs per analysis; sample throughput; turnaround time; and environmental, health and safety requirements.
Satisfactory results for a method can be obtained only with equipment that is performing well.
Special attention should be paid to those equipment characteristics that are critical for the method.
Analytical methods need to be validated or revalidated The FDA has also published a guidance for the validation of bioanalytical methods (8). The report presents guiding principles for validating studies of both human and animal subjects.
The most comprehensive document is the conference report of the 1990 Washington conference: Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies, which was sponsored by, among others, the American Association of Pharmaceutical Scientists (AAPS), the AOAC and the U. The report has also been used as a basis for the FDA industry guidance document (8).
Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.
Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.
Operators should be sufficiently familiar with the technique and equipment.Successful acceptance of the validation parameters and performance criteria, by all parties involved, requires the cooperative efforts of several departments, including analytical development, QC, regulatory affairs and the individuals requiring the analytical data.The operating procedure or the Validation Master Plan (VMP) should clearly define the roles and responsibilities of each department involved in the validation of analytical methods.For example, if detection limit is critical for a specific method, the instrument’s specification for baseline noise and, for certain detectors, the response to specified compounds should be verified.