What is GLP (Good Laboratory Practice)?
Good Laboratory Practice (GLP) is defined in the OECD Principles as “… a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported”. The aim is to ensure the quality, reliability and integrity of studies allowing the reporting of verifiable conclusions and the traceability of data. It must be noted that GLP is not directly concerned with the scientific design of a study and, it is also important to differentiate between the formal regulatory terms “Good Laboratory Practice” as opposed to the general application of “good practices” in scientific investigations. …show more content…
Even though hundreds of facilities around the world, including developing countries, have demonstrated the capability to successfully perform GLP compliant studies, others continue to argue these good scientific practices are too difficult for them to satisfy. Some researchers make the argument that since studies that do not meet these quality standards may be published in peer reviewed scientific journals, good science may be performed without GLP compliance. It is accurate to state that compliance with GLP regulations does not assure good science. Since good and bad science may be performed GLP compliant or non-GLP, this argument misdirects the discussion from the reason why the GLPs are required: to protect public health and safety. Because the data and reports of non-clinical safety studies are used to make public health decisions, it is necessary that these studies can be reconstructed from data that has the integrity, and GLP ensures the integrity of the …show more content…
Such personnel are found in the developed countries like USA, England, Russia and some European countries and certain developing but rich countries like; India, Japan, Malaysia and Hongkong. But developing countries which are poor are not able to provide such expert man power. Personnel working in the GLP field have very high stress on them by self they have to avoid minor mistakes also which may be dangerous. They have to provide the report of every work to their seniors also they have a pressure of
Good Laboratory Practice (GLP) is defined in the OECD Principles as “… a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported”. The aim is to ensure the quality, reliability and integrity of studies allowing the reporting of verifiable conclusions and the traceability of data. It must be noted that GLP is not directly concerned with the scientific design of a study and, it is also important to differentiate between the formal regulatory terms “Good Laboratory Practice” as opposed to the general application of “good practices” in scientific investigations. …show more content…
Even though hundreds of facilities around the world, including developing countries, have demonstrated the capability to successfully perform GLP compliant studies, others continue to argue these good scientific practices are too difficult for them to satisfy. Some researchers make the argument that since studies that do not meet these quality standards may be published in peer reviewed scientific journals, good science may be performed without GLP compliance. It is accurate to state that compliance with GLP regulations does not assure good science. Since good and bad science may be performed GLP compliant or non-GLP, this argument misdirects the discussion from the reason why the GLPs are required: to protect public health and safety. Because the data and reports of non-clinical safety studies are used to make public health decisions, it is necessary that these studies can be reconstructed from data that has the integrity, and GLP ensures the integrity of the …show more content…
Such personnel are found in the developed countries like USA, England, Russia and some European countries and certain developing but rich countries like; India, Japan, Malaysia and Hongkong. But developing countries which are poor are not able to provide such expert man power. Personnel working in the GLP field have very high stress on them by self they have to avoid minor mistakes also which may be dangerous. They have to provide the report of every work to their seniors also they have a pressure of