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Introduction

Good Laboratory Practice generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability of results as outlined in the organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.

Good Laboratory Practice belongs to the ever increasing number of “Good Practices”, starting with the Good Agricultural Practice and ending (probably) with the Good Zoological Practice. In many of these instances, the term “Good Practice” denotes nothing else than the established way of doing something, the way generally recognised as being the proper one. In many of these instances of “Good Practices” there are no “strings attached”, i.e. no specific rules are strictly to be followed in order to comply with the respective Good Practice. The area, where Good Laboratory Practice is employed, however, is of such importance, that the conduct of activities under its terms has to follow stricter rules than are recommended or prescribed in other areas of Good Practices. The difference to many of these other Good Practices, that most clearly separates Good Laboratory Practice from them, is that compliance to the rules of Good Laboratory Practice is of fundamental importance and necessity in the area of investigations into the safety of commercial (chemical) products. Another difference is that compliance to the Principles of Good Laboratory Practice, in company of a few other “Good Practices”, notably those strongly connected with the field of pharmaceutical manufacturing and testing, is monitored by governmental, regulatory bodies.

History of GLP

The formal concept of ‘good laboratory practice’ first evolved in the USA in the 1970s. The United States Food and Drug Administration (FDA) requires nonclinical studies of new drugs, food additives and chemicals to predict their safety and potential efficacy in humans. The significance of the information gained from these studies requires that they be conducted according to sound scientific principles and with strict attention to quality assurance and quality control. Human health and safety are dependent upon the decisions made from these studies. The discovery of the lack of companies' adherence to these principles led to the development of the good laboratory practice (GLP) regulations, the driving force behind the quality of nonclinical laboratory studies. As the 25th anniversary of the publication of the regulations approaches, a description of the events leading to the proposal of the GLP regulations provides understanding about their significance and the importance of their use in assuring the quality and integrity of nonclinical safety data.

Definition

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Need for GLP

GLP is needed to regulate all non-clinical safety studies that supports research and marketing permits for a product including veterinary drugs, aroma and color additives in food, medical devices and other bio-products. GLP can be applied to short term as well as long term studies. This regulation is a must for: