Performance verification

As described higher, the VERAPUS prototype system is designed to verify the ultrasonic flaw detectors used for non destructive testing, in the field of periodical amuially performed verifications which are described in CEN projects. 

Where the performance verification data indicate that method performance is not adequate, the method may be modified as appropriate and subsequently validated. 

This type of verification should be distinguished from the periodic performance verification, which monitors performance, e.g., in control charts. 

A final point is the value of earlier (old) validation data for actual measurements. In a study about the source of error in trace analysis, Horwitz et al. showed that systematic errors are rare and the majority of errors are random. In other words, the performance of a laboratory will vary with time, because time is related to other instruments, staff, chemicals, etc., and these are the main sources of performance variation. Subsequently, actual performance verification data must be generated to establish method performance for all analytes and matrices for which results will be reported. 

The final step of method development is validation of the HPLC method. Optimisation of chromatographic selectivity [110], performance verification testing of HPLC equipment [591], validation of computerised LC systems [592] and validation of analysis results using HPLC-PDA [34] were reported. The feasibility of automated validation of HPLC methods has been demonstrated [593]. Interlaboratory transfer of HPLC methods has been described [594]. 

F. Garofolo, Bioanalytical method validation, in Analytical Method Validation and Instrument Performance Verification (eds. C. C. Chan, H. Lam, Y. C. Lee and X.-U. Zhang), Wiley-Interscience, Hoboken, NJ, 2004, pp. 105-138. 

We start with a definition of the problem and based on this, we identify the candidates (such as, molecules, mixtures and formulations) through expert knowledge, database search, model-based search, or a combination of all. The next step is to perform experiments and/or model-based simulations (of product behavior) to identify a feasible set of candidates. At this stage, issues related to process design are introduced and a process-product match is obtained. The final test is related to product quality and performance verification. Other features, such as life cycle assessment could also be introduced at this stage. 

Calibration, in current Good Manufacturing Practices (GMP) terminology, refers to instrument qualification or performance verification... 

Calibration, in current Good Manufacturing Practices (cGMP) terminology, refers to instrument qualification or performance verification of the HPLC. Note that neither any internal instrumental adjustment nor detector response curve for quantitation is intended here as in the common usage of the terminology. In most pharmaceutical laboratories. 

FIGURE I I Exampie of pump performance verification document, as part of PQ protocoi. Courtesy of PerkinEimer LAS, Sheiton, CT. 

Periodic revalidation of a system can be accomplished by performing another PQ for that system however, a simplified version is often used. This task has been alternately described as re-calibration, recertification or performance verification. Regardless of what it is called, the accepted strategy should be defined in an SOP and the specific procedure... 

APPENDIX S—CALIBRATION AND PERFORMANCE VERIFICATION OF TRUE PEAK AND RMS MEASUREMENT INSTRUMENTS USED FOR TEST STAND ACCEPTANCE... 

The TRAACS 800+ is controlled by a personal computer and the features provided include complete interactive control via keyboard or mouse calculation of results as necessary taking into account baseline or sensitivity drift, graphical output of calibration curves for all calibration types—either Hnear or non-hnear, input facility for sample identification data allowing storage on disc and real-time results together with chart traces on a computer printer. The programs allow easy access to input or data files and connection to other computers, and gives system performance verification to CLP standards and built-in QC charts. 

Costs extrapolated from a U.S. Environmental Protection Agency (EPA) demonstration of BioLuxes in Denver, Colorado, have been reported as 28/yd for sites with 3500 and 4000 yd of contaminated soil. These costs exclude expenses associated with performance verification... 

The objective is to ensure that the freeze drying unit will operate and produce product quality results under load conditions. This will give a representation of long-term performance, verification of vendor guarantees for availability and failure rates, and a better debugged and more reliable system. 

Calibration or performance verification requirements, acceptance criteria, frequency of testing, and the actions required if the instrument, does not meet the performance verification requirements. 

Records Usage, maintenance, services, performance verification testing, and location of the records. 

Analytical Method Validation and Instrument Performance Verification, Edited by Chung Chow... 

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