Good Laboratory Practice methodology

For TM to be accepted into mainstream medical treatment, a likely scenario is the application of scientific methodologies and controls for TM development, evaluation, and production. Many of the tools for high throughput screening (HTS) and assay systems can be used to test the efficacy of TM, similar to the irrational approach of screening natural products. Pharmacology studies have to be conducted in accordance with Good Laboratory Practice (GLP). 

You have your methodology both verified and validated as required for measurements needing a high level of confidence. But, you must also assure that your analyst Is experienced In performing the type of analysis you need, that you have standards for the analytes available, and that you have a written quality assurance plan that documents good laboratory practice. 

STL are accredited by the Department of Trade and Industry via the National Measurement Accreditation Scheme (NAMAS). This covers all aspects of laboratory operations, such as organization of the laboratory and methodology, equipment and staff training, quahty-control systems and storage of data. The company acquired the first accreditation in the UK for the analysis of organic compounds by GC-MS. It also operates appropriate procedures to conform with the Department of Health s Good Laboratory Practice (GLP) recommendations. 

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

This chapter focuses on two main subjects. It will first deal with knowledge and methodologies of good practice in the study of chemical and microbial processes in wastewater collection systems. The information on such processes is provided by investigations, measurements and analyses performed at bench, pilot and field scale. Second, it is the objective to establish the theoretical basis for determination of parameters to be used for calibration and validation of sewer process models. These main objectives of the chapter are integrated sampling, pilot-scale and field measurements and laboratory studies and analyses are needed to determine wastewater characteristics, including those kinetic and stoichiometric parameters that are used in models for simulation of the site-specific sewer processes. 

The limit of sensitivity by the latest version (B21) is 0.05-0.1 ng of individual estrogen per sample, equivalent to excretion rates of about 6 ng/24 hours. While this method has not been applied to plasma and requires a good deal of know-how and manual skill, it is at present, in one of its forms, a must for any laboratory venturing into the more difficult areas of steroid methodology (see P3). Quite apart from the fact that current electron-capture-GLC or isotopic-labeling methods achieve little or no greater sensitivity in practice, they are considerably more laborious, the latter requiring up to J week for the analysis of 3-5 samples. 

If the reaction is incomplete after the first irradiation, a residual heat of reaction will be detected on the second irradiation. A good practice is to repeat irradiation cycles until two cycles are obtained that are indistinguishable from each other. This same methodology can be used to ascertain the completeness of cure of samples cured in laboratory and production processes, although additional measurement of Tg as an indicator of conversion is recommended. 

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