GOOD LABORATORY PRACTICES

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Good Laboratory Practices are defined by the Organization for Economic Cooperation and Development (OECD) as a set of rules and criteria for quality systems concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. GLP should be seen as a high-quality standard that ensures assay performance in a very organized and consistent manner for the results to be reliable. It must be followed to maintain dependably high standards and comply with internal company procedures, any regulations set by government agencies, and international regulations.

Test facilities such as laboratories conducting studies for submission to regulatory bodies adhere to the OECD Principles of Good Laboratory Practice. These studies aim to evaluate the health and environmental safety of chemicals and chemical products, including those of natural or biological origin. In some instances, these substances may also encompass living organisms. They also include the work conducted in greenhouses and for the agrochemical sector.

GLP is applied in the pharmaceutical industry, but not exclusively, as GLP applies to the non-clinical safety testing of items contained in pesticide products, cosmetics, veterinary drugs, food additives, and industrial chemicals. Specific studies include toxicity and mutagenicity assays, water, soil, and air behavior, bioaccumulation, and studies to determine chemicals residues in food or animal feedstuffs.  

Studies not under the scope of good lab practices would include basic research (non-clinical pharmacology units for mechanisms of action and efficacy). Discovery toxicology studies, nonclinical pharmacokinetics evaluation not part of a GLP study, and bioanalysis of samples.

This certification is aimed at improving the conceptual knowledge of the participant for Good Laboratory Practice and resolving any dilemmas that a working professional may face regarding the application of GLP guidelines at his workplace. Successful performance in this exam implies that the participant has in-depth knowledge and clear understanding of guidelines and regulations. The study material has been carefully designed to introduce the attendee to various aspects and basics of GLP, its need and benefits in assuring quality production. GLP has become an indispensable and integral part of any research lab. Be it medicines, cosmetics, biotechnology products, food supplements, new medical devices or any other healthcare related consumable product. Everything emerging in the market has to witness its first day in a laboratory surrounded by professional and skilled laboratory technicians. As part of their responsibility, scientists have conventionally adopted good laboratory practices directed at ensuring the quality of their data The case study based approach in the training provided for the certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified Good Laboratory Practice Professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. An advanced training having rigorous case studies based methodology will be imparted to all participants for preparing for the Certifying Examination