Good laboratory practice test system

Standard reference materials provide a necessary but insufficient means for achieving accuracy and measurement compatibiUty on a national or international scale. Good test methods, good laboratory practices, well-qualified personnel, and proper intralaboratory and intedaboratory quaUty assurance procedures ate equally important. A systems approach to measurement compatibiUty is ikustrated in Figure 2. The function of each level is to transfer accuracy to the level below and to help provide traceabiUty to the level above. Thus traversing the hierarchy from bottom to top increases accuracy at the expense of measurement efficiency. 

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). 

Good Laboratory Practice is a qnahty system concerned with the organisation of the test facility and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. This is the GLP Decalogue stating the basic principles that the laboratory must follow. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

Preclinical studies Studies that test a drug on animals and other nonhuman test systems. They must comply with the FDA s good laboratory practices. Data about a drug s activities and effects in animals help to establish boundaries for... 

The good laboratory practice criteria for whole effluent toxicity tests include species acceptability, exposure system conditions, physical and chemical conditions, and statistical data analysis methods. For instance, the test acceptability criteria for the larval fathead minnow 7 day chronic tests involves having 80% or greater survival of controls and an average dry weight of surviving control fish equal to or greater than 0.25 mg. 

Data are evaluated by considering their relevance to the measurement and assessment endpoints selected during problem formulation. The analysis techniques that will be used also are considered data that minimize the need for extrapolation are desirable. Data quality (e.g., sufficiency of replications, adherence to good laboratory practices) is another important consideration. Finally, characteristics of the ecosystem potentially at risk will influence what data will be used. Ideally, the test system reflects the physical attributes of the ecosystem and will include the ecological components and life stages examined in the risk assessment. 

Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice. 

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