THE LABORATORY IN OPERATION

Construction has been completed and equipment is coming in waiting to be set up, but the most important elements of the laboratory are still missing. Nothing can be done until people are present to run the equipment, interpret the tests, and write the reports. At this point, some time before the laboratory is scheduled to begin operation, important personnel decisions must be made. 

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In laboratories in operation for some time, there are often not enough electrical outlets or enough circuits to handle the load. Retrofitting for more power is very expensive. One laboratory received several bids for wiring their new facility. The accepted one was much lower than the others because money was saved by installing the bare minimum number of circuits and no spare circuit breakers. Every piece of conduit was jammed full of... 

Examples of Quality Audit report forms are shown in Tables 9.5 and 9.6 at the end of this chapter. Table 9.5 shows Report Form 1 which includes a record of what has been examined, so that subsequent audits can examine other aspects of the laboratory s operations. Note that when improvement actions are required, the form records not only what needs to be done, but also by when it must be completed, as shown in Table 9.6 (Report Form 2). The form is signed by the auditor and the responsible person from the area being audited. In the UK, the accreditation body UKAS refers to the corrective action as improvement action . This further emphasizes the continual improvement aspect of the ISO/IEC 17025 and ISO 9001 Standards. The examples shown in Tables 9.5 and 9.6 will probably have to be modified to meet a laboratory s particular requirements. It should also be remembered that both report forms should indicate (usually as a footer or header) the title of the document, its issue date, issue number, who authorized the document, page number and total number of pages. 

The kinetics of a liquid-phase chemical reaction are investigated in a laboratory-scale continuous stirred-tank reactor. The stoichiometric equation for the reaction is A 2P and it is irreversible. The reactor is a single vessel which contains 3.25 x 10 3 m3 of liquid when it is filled just to the level of the outflow. In operation, the contents of the reactor are well stirred and uniform in composition. The concentration of the reactant A in the feed stream is 0.5 kmol/m3. Results of three steady-state runs are ... 

The range of the work covered should be defined in detail, but the laboratory s operation should not be restricted by this definition. 

Where an evaluation indicates that the nonconfomting work could recur or that there is doubt about the compliance of the laboratory s operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly followed. 

In addition, suitable equipment and suitable monitoring and measuring devices should be available so that the laboratory processes operate effectively. The procedures for the release of the laboratory product, i.e. the acceptance of the laboratoiy resnlts as well as that for the delivery of snch results to the customers, have to be specified and controlled. 

Any property that belongs to the customer and is under the control of the laboratory in order to perform an operation or offer a service to this customer is administered with care. Customer property can include intellectual property. Examples of customer s... 

Business Continuity Planning (Disaster Recovery) A disaster recovery plan should be in place to ensure the continued operation of the laboratory in case of an adverse event that renders the instrument out of commission and hence causes interruption to the business processes which the system supports. Adverse events like the failure of the critical hardware components of the instrument and the failure of the application software do happen in the day-to-day operation of a laboratory. The disaster recovery plan should provide the necessary steps to restore the systems back to a functional state. The steps typically include instructions to reinstall the application software to the personal computer controlling the instrument, to reconfigure the instrument, and to restore the backup data to the instrument. 

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. 

If any individual P falls outside the designated range for recovery, that parameter has failed the acceptance criteria. When this situation occurs, a quality control check standard containing each parameter that failed the criteria must be analyzed independent of the matrix, that is, spiked reagent water, to demonstrate that the laboratory is operating in control. If this second test is failed, the sample results for those parameters are judged to be out of control, and the problem must be immediately identified and corrected. The analytical results for those parameters in the unspiked sample are suspect and may not be reported for regulatory purposes. 

Angus RG, Pigeau RA, Heslegrave RJ. Sustained operation studies From the field to the laboratory. In Stampi C, ed. Why We Nap Evolution, Chronobiology, and Functions of Polyphasic and Ultrashort Sleep. Boston Birkhauser, 1992 217-244. 

Operating accredited quality system is beneficial to the laboratory in the following ways ... 

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