Validation: Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. ...
The second is, that the required extent of a validation must only go as far as it is needed for the goal of the application of the method. ...
Validation of each assay or test method should be performed on a case-by-case basis, to ensure that the parameters are appropriate for the method’s intended use. Typical analytical performance parameters used in validation include:
Accuracy: It is the closeness of agreement between the value which is accepted either as a conventional true or an accepted reference value, and the value found. ...
Specificity: An investigation of specificity should be conducted during the validation of identification tests, the determination of impurities and the assay. ... The protocol should clearly indicate the method’s intended use and principles of operation, as well as the validation parameters to be studied, and a rationale for why this method and these parameters were chosen.
Design a validation protocol that ensures the reliability of the methodology of your choice. ... A full method validation requires a rather high workload and should therefore only start when promising results are obtained for the explorative validation performed during the early drug development phase, ie. ...
The main focus during this early stage of the validation should then be on the study of the calibration range in order to provide the basis to select an appropriate calibration model and to define the concentration range within which it is likely that the method will satisfy the acceptance requirements. ...
A verification and validation system should be employed so as to ensure that the computer systems being used are working perfectly by analyzing the software and controlling its performance. ...
The objective of the validation of the software is to control that everything works perfectly and no abnormal function is performed. Software validation and verification evaluates how well the software is meeting its technical requirements and safety, security and reliability objectives relative to the system. ...
Conclusion
The continuos validation process enables the analyst to monitor performance of the method over time and be confident that valid sample concentrations are being generated.
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