Designated laboratories test samples, preparation

In order to obtain reproducible results, special care must be given to panel selection and panel education, testing facilities, sample presentation and the design of each test. Modern sensory facilities display a kitchen/laboratory for sample preparation as well as separate sensory booths with controlled air and lighting. The evaluation of the sensory results can be supported by specialised computer software packages. 

For analytical testing, the BPI may refer to a separate analysis instruction designed to test the preparation or the specific dosage form. When analysis is outsourced, the BPI may mentimi that a sample should be sent to the approved laboratory. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

Sample preparation procedures and analytical techniques for the off-site laboratories of the CWC have been developed and tested in five international interlaboratory comparison (round-robin) tests (1 5), in two trial proficiency tests, and in more than 14 official proficiency tests (see Chapter 6). The Recommended Operating Procedures (ROPs) for sampling and sample preparation (6,7) were written and updated on the basis of the results of the round-robin tests. The ROPs (see Table 1) were designed to be comprehensive enough to allow the analysis of all CWC-related chemicals. Accordingly, some of the procedures contain many sample preparation steps. It is also recommended that the ROPs should be used as first choice in the analysis, with other approaches not excluded. 

A manufacturer s quality control laboratory shall be separated from the production area and ideally should be in a separate building. The control laboratory should be designed and equipped and of such a size as to be a self-contained entity, with adequate provision for the storage of documents and samples, preparation of records and performance of the necessary tests. 

A laboratory test must be designed and performed so that the most important parameters from an atmospheric corrosion perspective are controlled. Reproducibility and the ability to mimic the atmospheric corrosion in different ambient environments are other important criteria of a laboratory test. Parameters to consider in accelerated tests are sample preparations prior to exposure, relative humidity, temperature, exposure time, corrodents, and corrodent delivery rate [1]. 

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