Good laboratory practice protocol

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. 

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. 

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. 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

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. 

When the first draft of a protocol is typed, it is sent to the Quality Assurance Section to be audited. The protocol is checked for those details required by the Good Laboratory Practices guidelines. Comments about each protocol are sent to the study director. When the final version of the protocol is typed, it is again sent to Quality Assurance for review. The original copy of the signed and dated protocol is filed in the archive. 

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). 

Good Laboratory Practice Acceptance of results and conclusions from a validation study may be compromised if the principles of GLP are not applied during the study. While this is unlikely to be an issue for industrial laboratories, it may be a more important concern in academic laboratories where adherence to GLP traditionally has been less of a concern. All efforts should be made to ensure that the principles of GLP were adhered to in all participating laboratories. This in large part can be achieved by determining whether the participants followed common protocols, SOPs, and data reporting procedures. 

Errors can be introduced through experimental design or the procedures used for measurement and sampling. Such errors can be reduced by adherence to good laboratory practices and adherence to established experimental protocols. Errors also can be introduced during simulation model development. Uncertainty in the development and use of models can be reduced through sensitivity analyses, comparison with similar models, and field validation. 

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