Protocol, good laboratory practice standards

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. 

Today, much more than just data are produced electronically. Many documents needed for studies that fall under the Good Laboratory Practice (GLP) standards regulations are being managed electronically. These records include not only data, such as chromatographic data from automated electronic capture systems and raw data collected in electronic field notebooks, but also other documents, such as methods, protocols, reports and standard operating procedures (SOPs). Frequently, these records are generated, distributed, reviewed, and archived electronically. 

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. 

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. 

Good laboratory practice (GLP) A system of protocols (standard operating procedures) recommended to be followed so as to avoid the production of unreliable and erroneous data. Accurate record keeping and careful forethought in the design of the study are important aspects of GLP. 

The studies are done according to a standardized OECD protocol and in compliance with good laboratory practices. Test results are reviewed by the responsible government entity within the country with lead responsibility. Dossiers are subsequently reviewed by an international committee of experts. 

Other standard protocols to which an analytical laboratory may need to seek compliance include GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice) and CPA (Clinical Pathology Accreditation). 

In this section we provide some practical considerations to chemists not familiar with the use of immunoassays for food contaminants. We focus primarily on the use of 96-well microtiter ELISA. Regardless of the type of sample and analysis, good laboratory practices (GLPs) and international standards organization (ISO) standards, where they apply, need to be followed to ensure the quality of results and the minimization of variability. Like any other analytical protocol, the analysis of contaminants by immunoassay is a combination of three sequential steps sample collection and preparation, sample analysis, and data processing followed by the interpretation of results. 

In this way, the operational range of the Kolbe-Schmitt synthesis using resorcinol with water as solvent to give 2,4-dihydroxy benzoic acid was extended by about 120°C to 220°C, as compared to a standard batch protocol under reflux conditions (100°C) [18], The yields were at best close to 40% (160°C 40 bar 500 ml h 56 s) at full conversion, which approaches good practice in a laboratory-scale flask. Compared to the latter, the 120°C-higher microreactor operation results in a 130-fold decrease in reaction time and a 440-fold increase in space-time yield. The use of still higher temperatures, however, is limited by the increasing decarboxylation of the product, which was monitored at various residence times (t). 

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