Validation methods measurement technology

Studies undertaken by LGC during the VAM 1994-1997 programme have demonstrated that a large number of generic problems need to be addressed before the potential power of nucleic-add-based methods can be reliably applied. The main outputs of the DNA technology validation project in the new programme will be validated novel measurement systems which utilise DNA technological procedures, quality protocols, and reference materials. 

In the development of new analytical methods, the use of well-characterized reference materials can be invaluable in comparing measurement technologies, assessing potential sources of bias, and in method validation. Reference materials are also useful as controls for quality assurance. Reference materials produced by national metrology institutes are usually classified as certified reference materials (CRMs) ... 

As measurements of interactions often happen in dissected systems where molecules are tested in other than the original context, it should be crucial to test a model in conceptually different assay set-ups to validate findings and try to eliminate experimental artefacts. These requirements can be difficult to achieve for the carbohydrate-carbohydrate interaction even more difficult than to find the natural components of protein-carbohydrate interaction which is already a difficult task as demonstrated by the hunt for the real selectin ligands [103]. Much of older literature on carbohydrate-carbohydrate interaction does not necessarily hold the requirements for unambiguous testing in different systems, but due to lack of possible alternatives at the time they were performed they have been included in this summary. Improvement of methods and technology should give the chance to test these concepts in future. 

Proper control of food irradiation applications should fulfill the requirements for both food technologies and radiation technologies. Application of well-established methods for measurement of absorbed radiation dose and the dose distribution helps to provide assurance that the radiation treatment is both effective and legally correct [133]. Computer tomography (CT) can provide detailed, high-resolution, and accurate dose maps for any arbitrary product and package configurations [134]. Such dose maps are an essential part of process validation. 

Earlier I discussed a method of planning for PV, in particular the overall development function leading up to it. It appears that the development group has a number of avenues that will lead to the appropriate validation approach it takes. In one approach, the critical process parameters would be measured to monitor the process and document the fact that the process is validated. Many validation programs use this approach, but they are usually undertaken right after or as part of the technology transfer effort. 

Gad SC, Dunn BJ, Gavigan FA et al. (1987) Development, validation, and transfer of a new test system technology in toxicology. In Goldberg AM (ed) New Test System in Toxicology. Mary Ann Liebert, New York, pp 275-292 Van Loveren H, Kato K, Ratzlaff RE et al. (1984) Use of micrometers and calipers to measure various components of delayed-type hypersensitivity ear swelling reactions in mice. J Immunol Methods 67 311-319... 

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