Good Laboratory Practice

• Definition
• History
• Applications
• Standard Operating Systems

Definition

Scientific work is conducted under a legal framework, which governs not only the health and safety of workers but also the conducting and recording of experiments for protection of intellectual property (IP) rights. Industrial laboratories work according to Good Laboratory Practice (GLP) conditions, which specify the organisational process and conditions under which studies are planned, performed , monitored, recorded and repeated. GLP seeks to ensure, as far as possible, the quality and integrity of data for non-clinical laboratory studies.

History

GLP regulations were first published by the USA's Food and Drug Administration (FDA) in 1976. At that time the FDA identified significant problems in the manner in which non clinical studies were being performed in the USA. Deficiencies were found during inspections of major pharmaceutical firms, private testing facilities and government laboratories. The result of these experiences heralded the birth of GLP.

Applications

Essential elements of GLP include personnel, management, the responsibilities of study directors, quality assurance, laboratory operations , equipment testing, standard operating procedures (SOPs ), reporting and storing in archives, together with other aspects of regulatory compliance. Although academic institutions such as universities operate mainly outside GLP regulations, the model is followed as closely as is practicable.

Health and safety for all laboratory workers, has become a key issue in recent years, with government legislation enforcing strict codes of practice. In the UK, for example, detailed COSHH forms (Control of Substances Hazardous to Health) must be completed either by individuals for personal use or by managers in charge of laboratory workers, detailing precisely the experimental procedures and levels of exposure to potentially hazardous chemicals. Toxicity data for potentially hazardous substances are available through a variety of databases;

Standard Operating Procedures

An SOP is a written procedure that all workers must follow when performing a routine laboratory task. Most SOPs detail the steps of an operation in the order in which they should be performed. An SOP is a complex document. The writer must deal not only with the steps required in an operation, but also with the nature of the task, the ability of the worker to accomplish the task , and the worker's ability to follow instructions and understand the risk of each assignment and the hazards associated with it.