Quality Assurance and Good Laboratory Practice

Analytical data need to be comparable between different laboratories on an international scale. This presupposes that the quaUty of the data is assured. In addition, planning, performance, reporting, and archiving of tests should be regulated. 

A central point of comparability of analytical data is an appropriate system of quality assurance. According to DIN 55350, quality is defined by 

The total of properties and features of a product or an operation to fulfill predefined requirements. 

It therefore becomes necessary to quantify quality in the frame of quality assurance tests. Quahty assurance comprises all activities that lead to fulfillment of the defined requirements. They include the totality of operations in quality management, quality planning, quality directing, and quahty tests. 

If the requirement cannot be fulfilled, then an error is made according to the DIN directive. If the error restricts the applicability, it is termed a lack. Typical in analysis are random and systematic errors, false-positive or false-negative detection results, or the complete failure of an analytical determination. 

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Danzer K (1993) Information content of an analytical result and its assessment by interlaboratory studies. IDF Special Issue 9302 Analytical quality assurance and good laboratory practice in dairy laboratories. IDF, Brussels... 

The individual scientist is the key to the production of quality data and must have technical competence and a dedication to quality work. Passive following of good laboratory practices and good measurement practices is not enough. Involvement in their development is required if the quality assurance program is to be credible. Standard operations procedures (SOPs) do not minimize the need for technical competence. Analysts exhibit varying degrees of proficiency when... 

Issues of quality extend far beyond organizational arrangements. The analyst and the employer must both accept the equally important aspect of quality in professional skills and competences. Analysts need more help in order to learn about good laboratory practice and to work competently and professionally on a day-to-day basis within the framework of the VAM principles. This book offers analysts a new learning route to achieving these aims, and employers a convenient way to introduce quality assurance procedures. 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

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. 

It is important to ensure the quality and reliability of safety studies. This is normally assured by following the Good Laboratory Practice regulations. Any deviation from this must be justified. 

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. 

Two American Chemical Society short courses were instrumental in the development of this manuscript. These were (1) "Quality Assurance in the Analytical Testing Laboratory/ taught by Gillis and Callio, and (2) "Good Laboratory Practices and ISO 9000 Standards Quality Standards for Chemical Laboratories," taught by Mathre and Schneider. 

The reliability of measurements plays a pivotal role in food and agricultural areas, particularly in the case of undesirable toxic compounds such as mycotoxins. Quality-control principles for mycotoxin analysis are common to other trace analyses, so good laboratory practices, such as EN 4500, represent the heart of quality assurance requirements. Harmonized Guidelines for Internal Quality Control in Analytical Chemistry Laboratories, published by IUPAC (23), also presents valuable guidelines for the determination of mycotoxins. 

Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. 

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