Quality control equipment accuracy

Laboratory equipment and procedures must be qualified and validated. Every NDA/ANDA inspection will include both an evaluation of laboratory controls and procedures and an audit of some of the raw data used to generate results. These data may be located in research and development test logs. The authenticity and accuracy of data used in the development of a test method should be established. (See the Guide to Inspection of Pharmaceutical Quality Control Laboratories, July 1993.)... 

CRMs are an important tool for quality assurance and quality control in analytical laboratories. They are used for verification of accuracy and precision (i.e., reliability of the results of analysis, validation of analytical procedures, establishing measurement traceability, and calibration of measurement equipment). Use of CRMs is recommended by the ISO/IEC 17025 standard and therefore it is obligatory for those who wish to obtain and maintain accreditation of the laboratory. 

The inherent accuracy and precision of instruments have a profound influence on the quality of the results they produce. In addition, instrument malfunction is now recognized as a potential source of error, and one survey ascribed 18% of the errors detected as due to equipment (W17). Such errors are usually detected by quality control of the complete analysis, but identification of the cause is more difi cult and is often unsuccessful because of the lack of suitable methods of quality control of instruments. If these were applied as part of regular maintenance, errors would undoubtedly be identified more rapidly and before they significantly affected the analysis. 

The standardization of spectrochemical procedures is difficult owing to the variety of material analyzed and the impossibility of producing a standard identical in composition to the sample. It is therefore necessary to determine the extent of interfering effects and to use a standard which will compensate for these. However, CV of better than 3% can readily be achieved with accuracies of the same order at the 0.1 /ig/ml or 10 g level. Spectrochemical methods of analysis are accurate and rapid when correctly used, but as the equipment becomes more complex, the operating procedure, quality control and the maintenance necessary to ensure reliability also becomes more elaborate. 

Dose calibrators are standard equipment in all nuclear medicine facilities. They are used to measure the dose of radioactivity of all drugs administered. Because quantitative outcomes based on administered dose are dependent on the exactness of the dose measurement, the accuracy of the dose calibrator must be ensured with routine measurements using reference standards. Quality control and calibration of the scanners must also be scheduled on a regular basis to maintain proper performance. Because a variety of 2D and 3D scanners is used, variability in performance can be a major issue [70]. 

In addition to the mass spectral aspects of these assays, which are outlined below, there may also be extensive requirements to be met by the analyst with respect to compliance with good laboratory practice, which governs the operations of analytical laboratories and includes sampling regimes, assay validation procedures (e.g., limits of detection, limits of quantification, accuracy, reproducibility, and ruggedness), and laboratory accreditation (e.g., staff training, laboratory equipment, documentation, quality assurance, and quality control).142-145... 

FdPLC has contributed many successes in product development and in quality control for the pharmaceutical industry. The UV detector coupling with HPLC equipment is the most important analytical instrument for preformulation, QC/QA, and in-process control in pharmaceutical analysis. HPLC is a basic and reliable analytical tool for preformulation study because of the high-resolution capacity, accuracy, and reproducibility of the equipment. Its primary function includes search for and detection of impurities in drug substances, as well as stability evaluation of dosage forms in terms of detection and quantitation of degradation products. 

Titrimetry is one of the oldest analytical techniques, originating in the middle of the eighteenth century as a rapid means of quality control of industrial processes, such as acid manufacture. Since that time, the equipment has been refined, the procedures have been automated, and the number of chemical reactions utilized greatly increased, but the basic principles are unchanged. Its continued popularity stems from the simplicity of equipment and execution, wide applicability, and high accuracy and precision (greater than most instrumental techniques), all of which make it particularly applicable to the determination of major and minor components of samples. Skilled titrimetric analysis should give results with a precision of <0.2% at the 1 X 10 moll level. 

In clinical chemistry AAS is preferred for the determination of trace metals due to practicability, time needed for analysis, cost of equipment, and possibility of automation. In past years the AAS technique has been improved so effectively that excellent results in terms of precision and accuracy can be obtained. External quality control measures have confirmed this conclusion. 

Quality control is dependent on available high-quality reference materials (RM) for which one or more properties are sufficiently established to validate measurements. A certified RM (CRM) is traceable to a certificate or other documentation issued by a certifying body and provide the essential traceability in measurements. CRMs are used to demonstrate the accuracy of results, to calibrate equipment, and to validate methods. 

Quality control procedures are used to lessen or at least understand the extent of errors introduced by chemical feed systems. Therefore, awareness of the error allows for its correction or compensation. The degree of accuracy of chemical feed can affect the cost of treatment when more chemical is used than is needed. Also, inaccurate feed systems can hide leaks and other losses. It is important to use equipment that has suitable accuracy. 

As a commercial company that provides analytical services for the determination of radionuclides for a wide variety of clients, AMEC required a more accurate and reliable method to be developed. It needed to use relatively low hazard chemicals, have improved accuracy and precision and utilise common radiochemical analytical laboratory equipment such as liquid scintillation counters and gravity fed chromatography columns. In addition, the process must have realistic and commercially viable batch sizes, operator time and turnaround times, so that samples can be analysed in a cost-effective manner. Ideally the whole process for a batch of samples should not exceed more than one working week. As part of the validation process both internal and external quality control (QC) samples were used along with statistical tests, such as zeta (Q scores and student t-tests , to determine the accuracy of the improved method. In addition, elution profiles for iodine and chlorine and decontamination tests for potentially interfering radionuclides were also carried out in order to further validate the process. 

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