The use of information in production is much more driving force in today's business world, where the concepts of time and space change. This is also a way of achieving competitive advantage in international markets. In order to keep production alive, production tools need to be used more intensively. It is also very important to be structured according to the new world structure.
Good Laboratory Practicesis involved in the activities planned, implemented, followed, recorded and reported by the laboratories and the functioning of these institutions.
GLP Good Laboratory Applications System Thanks to the principles, the studies in the test areas are planned appropriately and they are operated using adequate tools.
Although there are important developments in the field of laboratory services in our country, our laboratories are not sufficiently recognized at national and international level and desired value added has not been obtained. In addition to strengthening the infrastructure of laboratories, it is necessary to operate in accordance with international standards and to develop forward-looking strategies.
In a study conducted in the US laboratories in the early years of 1970, it was revealed that these laboratories were not well managed, their employees were not adequate, and the reports were improperly prepared. In addition, it was observed that the protocols were inadequate, they were designed without planning, the raw data was collected incomplete and misidentified and approved by unauthorized persons. In addition, it was determined that the regular calibration of the instruments used in the tests was not performed and the correct archiving was not performed. As a result, studies have been initiated to improve laboratory studies. In 1976, GLP, Good Laboratory Practice drafts were prepared and published in 1979.
The GLP Good Laboratory Practices System is a quality system for planning, conducting, monitoring, recording, archiving and reporting of health and environmental safety studies, apart from clinical studies.
The main objective of the system is to support the laboratories to ensure the reliability, reproducibility and controllability of analytical results and their recognition in the international market.
In our country, there are two regulations on this subject: Regulation on Good Laboratory Practice Principles and Certification of Test Laboratories and Regulation on the Supervision and Control of Good Laboratory Practices. These Regulations have been prepared in accordance with the Directives on the supervision of the principles of good laboratory practice and the control of the works within the scope of the European Union harmonization studies. Both regulations cover the principles of inspecting the laboratory conditions in which the test studies are planned, performed, recorded and reported in accordance with the standards described.
By the way GLP Good Laboratory Practices System Certificateis a document that determines that laboratories are in compliance with system principles and standard operating procedures.
The laboratories that set up and manage the GLP Good Laboratory Practices System reveal the reliability of the test data. This system requires the installation of a complete documentation system. Documents are used in the methods used, procedures, deviations and many more. With the help of the system, studies with a correct planning can be monitored and the reports produced as a result of the study can be controlled by third parties.
GLP Good Laboratory Practice System standards internationally, and the tests and results obtained in these laboratories are accepted worldwide.
In the GLP Good Laboratory Practices System, it does not impose rules on how to perform tests in laboratories, or on the planning and scientific content of the work. However, it wants to fulfill some responsibilities.
The GLP Good Laboratory Practice System addresses laboratory work in five key areas: resources, rules, characterizations, documentation and quality assurance.
The purpose of the GLP Good Laboratory Practice System can be summarized as follows:
• Ensure that the test results are reliable and high quality
• Improving the protection of human health and the environment
• Prevent repeated tests, thus saving time, cost and resources
• To enable mutual acceptance of Tets results
GLP has some responsibilities to the parties in the implementation of Good Laboratory Practices standards. For example, laboratory senior management must take the necessary measures to ensure good laboratory practices are complied with. Employees are obliged to implement safe working techniques during the tests and take the necessary precautions before the hazard emerges. In addition, it has to take measures to minimize the risks that would jeopardize its health and the accuracy of the work. Persons responsible for the activities of employees must ensure that the tests are completed and reported.
In laboratories, there should also be a quality assurance program in order to ensure that the GLP Good Laboratory Practices System is established and that test studies are carried out in accordance with GLP standards.