Chromatography: Validation, SOPS and System Suitability

Essay by filocanUniversity, Bachelor'sA+, May 2006

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Equipment Validation Protocol

Validation is the process to confirm that the procedure in use for a definite test is appropriate for its proposed use. Methods require validation or revalidation before the introduction of the equipment to routine use. Method validation is different than equipment validation, as method validation adheres to the methodology of the experiment, while the equipment validation refers to the apparatus being used, such as the column.

The basic concept behind validation is simple. It is to prove that the results generated by a system can be trusted. Unfortunately, generating the proof tends to be a tedious chore, and so is the job of keeping all the documentation in order. The process of validation is tedious and time consuming. There is usually specialized software programs set up with attachment to the instrument to perform he validations as the process of the instrumental analysis.

Installation qualifications, operational qualifications, functional test specifications and performance qualifications must be met with the proper use of the instrument.

Areas that are covered in the method validation include:

Specificity - analyte should have no interference from other extraneous components and be well resolved from them

Selectivity - the degree of how selective the method is to detection of the analyte

Precision - the measure of how close the data values are to each other

Repeatability - the relative standard deviation between separate injections of the same sample

Intermediate Precision - ensure that the method will provide the same results when similar samples are analyzed once the method development phase is over

Reproducibility - expresses the precision between laboratories as in collaborative studies

Accuracy - the measure of how close the experimental value is to the true value

Trueness - reliability and accuracy

Bias - statistical sampling or testing error caused by systematically favouring some...