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Good laboratory practice equipment

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. [Pg.100]

The principles of Good Laboratory Practice are complied within its laboratory, a Laboratory Policy exists and it is communicated and understood by the laboratory personnel, a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available in the laboratory and proper training and relevant ... [Pg.101]

The recent amendment in November 2008 to the drugs and cosmetic rules (II) includes a new Schedule L-1, which covers the Good Laboratory Practices and Requirements of Premises and Equipments, primarily for laboratories that support manufacture. Despite such specific emphasis of its applicability, the details of GLP requirements are in general alignment with those of the OECD, USFDA, USEPA, etc. [Pg.23]

Dew-point measurement is a primary method based on fundamental thermodynamics principles and as such does not require calibration. However, the instrument performance needs to be verified using salt standards and distilled water before sampling (see Support Protocol). To obtain accurate and reproducible water activity results with a dew-point instrument, temperature, sensor cleanliness, and sample preparation must be considered. Equipment should be used and maintained in accordance with the manufacturer s instruction manual and with good laboratory practice. If there are any concerns, the manufacturer of the instrument should be consulted. Guidelines common to dew-point instruments for proper water activity determinations are described in this protocol. The manufacturer s instructions should be referred to for specifics. [Pg.42]

Closely related to preventive action is the process audit. Such an audit is performed as part of a laboratory assessment for each test on the proposed scope of accreditation. Performance of a test procedure is observed relative not only to the requirements of the ISO 17025 standard (or ISO Guide 25) but also with respect to performing the ASTM or ISO test method properly. As a minimum, the laboratory must have properly calibrated equipment, the current test method, and trained testing personnel. In addition, a representative number of test demonstrations will reveal whether good laboratory practices are observed in sample preparation, using the correct test parameters and calculating the results. When operators and technicians accept responsibility through such demonstrations, they tend to commit to the quality process. Real improvement occurs with involvement at all levels. [Pg.84]

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... [Pg.367]

This chapter reviewed a systematic approach to method development, validation of analytical methods, and successful transfer of the methods. Successful completion of each component is both a regulatory requirement and good laboratory practice. To ensure that the data are both accurate and reliable, qualified and trained laboratory analysts must perform methods on qualified equipment, using suitable standards. [Pg.441]

The exact definition of good laboratory practice depends on who is defining it and for what purpose. A broad definition encompasses such issues as organization of the laboratory, management, personnel, facilities, equipment, operations, method validation, quality assurance, and record keeping. The goal is to certify that every... [Pg.125]

The means for obtaining high quality, cost effective analytical services are described. These services are essential for accurate and economical analysis with rapid turn around time. Good laboratory practices, including computerized sample tracking, instrument calibration, maintenance of equipment and written documentation of the analytical methods assure high quality of the analytical data. [Pg.891]

For the determination of trace metals in biological materials, in addition to Good Laboratory Practice further particularities have to be respected because the metal concentration in the matrix is extremely low. The most important disturbances are caused by contamination. The falsification of the results can be so enormous that these become nonsensical. Sources of contamination include the utensils used in sample preparation, all equipment having contact with the samples in the analytical procedure, water, reagents, and components in the environment. Because of the low metal content in the samples, instability of the solutions and matrix effects play an important role. Therefore standards and reference materials as well as the analytical procedure have to meet extremely high requirements [35,36]. [Pg.18]


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