Good laboratory practices: A case study in a pharmaceutical R&D center

Good Laboratory Practices(GLP) is a quality management system, transferred to the acquis of the European Union upon being adopted by the European Union and developed by the Organization for European Economic Cooperation in order to provide mutual acceptance of data among countries by way of securing trustworthiness and quality of data obtained through nonclinical laboratory studies conducted for searching the effects of substances and products on health and environment, which is necessary for license, authorization and registration applications filed before the authorities in accordance with the relevant legislation for the launch of the chemical substances and the chemical products such as medications, cosmetics, pesticides, food and animal feed additives into the market. It aims at decreasing the use of animals in experiments, preventing the loss of resource and time as well as unnecessary repetitions of tests by way of mutual acceptance of data among countries, and it makes an important contribution to the protection of human health and environment, obtaining good quality and trustworthy test data, reducing public and industrial expenses and development of international trade of chemical substances and products.In the first part of the study, Turkish drug industry and quality and the importance of quality in the drug industry are being handled. In the second part, the importance of laboratories in the drug industry, effective use of laboratories and the regulations which need to be followed for international acceptance of the data to be obtained from laboratories are mentioned. In the third part, a case analysis conducted through the survey method at an R&D institution which is active in the industry, and the statistical data regarding this study are presented and interpreted. In the fourth and last part of the study, facts obtained at the end of the study are presented, and suggestions are made especially for the Research & Development laboratories active in the drug industry as well as for the laboratories of human drugs, veterinary drugs, agricultural drugs, food and animal feed additives and cosmetic products.