Good laboratory practice quality control

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The above list of potential advantages of automated immunostainers summarizes their strengths. Automation cannot, however, correct faulty cell or tissue preparahve techniques, which would lead to the failure of any immunostaining method. Automated staining also cannot correct for the improper selection of tissue to be examined, or for selection of antisera and associated reagents that produce nonoptimal or inconclusive results. Automation is no panacea for laboratories that have poor quality control procedures, since good laboratory practices are required to operate automated Stainers successfully. 

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. 

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. 

Owens MA, Loken MR (1995). Flow Cytometry Principles for Clinical Laboratory Practice. Wiley-Liss/John Wiley and Sons, Inc, New York. A discussion of the theory and practice of clinical flow cytometry, with some good emphasis on quality control. 

Good science exists in research in academic institutions apart from the soon to be established Environmental Protection Agency s (EPA) Good Laboratory Practice (GLP) guidelines. However, this is not to say that GLP s are not advisable. Good science should be able to stand up to review as having been performed using appropriate and adequate laboratory practices. Scientists have had their work routinely scrutinized by their peers for its quality and will not resent careful analysis by others. For example, only a portion of the work produced by the scientific community is acceptable for publication in its various journals. The rate of acceptance in journals varies but it is apparent that the peer review system attempts to serve as a quality control mechanism in the scientific community. 

The reviewer should establish that the laboratory reporting the study has the necessary professional reputation, scientific experience, and expertise in the area investigated. It should be confirmed that adequate quality-control facilities are in place and good laboratory practices and procedures followed. 

Calorimetric methods are infrequently used for routine quality control purposes because of their non-specific nature and relatively slow speed. However, data from calorimetry experiments are commonly presented in applications for new product licenses and in support of patent applications. To ensure the integrity of all calorimetry data, normal procedures for good laboratory practices, standard operating procedures, appropriate calibration methods, and regular instrument servicing are necessary. The use of DSC for the measurement of transition temperatures and sample purity is described in the United States Pharmacopoeia, and standard procedures for DSC analyses are also suggested by the ASTM (100 Barr Harbor Dr., West Conshohocken, Pennsylvania 19428). 

Good Laboratory Practices (GLP) regulations insist on the appropriate management of animal data so that quality assurance/quality control (QA/QC) personnel can, at any time, select an animal number... 

Such test guidelines often form a key part of a laboratory s formal quality assurance procedure (e.g. Good Laboratory Practice or other formal accreditation schemes) and enable test results to be audited. However, to be fully effective these quality assurance procedures need to take account of the performance characteristics of the test (quality control). Such considerations form the basis of the following section. 

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... 

Assessment of contracted-out services, e.g. by storage and distribution agents, contract research organizations (CROs) and quality control laboratories for compliance with GMP, good clinical practices (GCP) and good laboratory practices (GLP), are further elements that may supplement the prequalification process. 

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