The transfer of validated methods
Duration: 60 Minutes
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage and handling procedures, and other variable are common and can lead to different results. Making each operation as similar as possible can be time-consuming and complicated.
- The statistics of analytical methods
- Defining universal standards
- Making method operation uniform
- Training issues
- The use of Round-robin Samples.
- The Statistic of Transferring Methods
Many methodologies are used in more than 1 facility. A common practice is that a method is developed at a R&D laboratory and then transferred to operating facilities to use. It is well known that there can often be no relationships between neither accuracy nor precision values running the same method in different laboratories. The use of universal standards, making operations as identical as possible, round-robin testing, and rigorously uniform training and methods are necessary.
- Lab Chemists
- Lab Managers
- Lab Technicians
- Lab Analysts
- Industries into Compliance Methodology (Biotech, Pharma) Companies into Environmental Compliance or EPA
John C. Fetzer has had over 30 years of experience in laboratory compliance, including developing methods, writing SOPs, training, and auditing. He has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
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