Field studies, good laboratory practice

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

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. 

Extension of Good Laboratory Practices to Field and Residue Studies... 

Garner WY, Barge MS, Ussary I.P (eds) (1992) Good laboratory practice standards. Applications for field and laboratory studies. ACS, Washington DC... 

Garner, W.Y., M.S. Barge and J.P. Ussary (Eds) (1992). Good Laboratory Practice Standards Applications for Field and Laboratory Studies, American Chemical Society, Washington, DC, USA. 

One of the misconceptions about GLP which has already been mentioned earlier is simply connected with the terminology The name, the Good Laboratory Practice , implies that any laboratory capable of faultless operation and quality work must conduct its activities under the auspices of Good Laboratory Practice. The name seems thus to have completely usurped the quality field with respect to work conducted in laboratories. In reality GLP has a strictly defined area of application, which includes only some types of laboratories, and some types of studies, as has been described earlier (see section 4, page 25). Other quality systems do exist, however, which may apply to those laboratories and the work conducted therein, which are falling outside the area of GLP. They will be better tailored not only to the needs of sponsors and laboratories alike, but indeed to the type and nature of the work conducted in those types of laboratories. 

Non-clinical health and environmental safety studies covered by the Principles of Good Laboratory Practice include work conducted in the laboratory, in greenhouses, and in the field. 

The preclinical testing itself is performed by specialists in this field and is often outsourced to Contract Research Organization that should perform the studies conforming to the standards of Good Laboratory Practice (GLP in Europe as defined by the OECD). 

Good Laboratory Practice Standards Applications for Field and Laboratory Studies... 

This chapter focuses on two main subjects. It will first deal with knowledge and methodologies of good practice in the study of chemical and microbial processes in wastewater collection systems. The information on such processes is provided by investigations, measurements and analyses performed at bench, pilot and field scale. Second, it is the objective to establish the theoretical basis for determination of parameters to be used for calibration and validation of sewer process models. These main objectives of the chapter are integrated sampling, pilot-scale and field measurements and laboratory studies and analyses are needed to determine wastewater characteristics, including those kinetic and stoichiometric parameters that are used in models for simulation of the site-specific sewer processes. 

For a good design one often needs to do research - to make desk studies, try out things in the workshop, and - especially - experiment in the laboratory or in the field. This work can be applied and practical, but also very fundamental. However, the research part of product development differs from the largely curiosity-driven and exploratory research of many university departments in one important way it does not go further than needed for the development of the product. Time is a real constraint in development ... 

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