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The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
Example of a label showing the amount of niacin (Vitamin B3), and specifying to be niacinamide in the ingredient section.. The United States Government adopted the terms niacin and niacinamide in 1942 as alternate names for nicotinic acid and nicotinamide, respectively, and encouraged their use in nontechnical contexts to avoid the public’s confusing them with the nearly unrelated (and toxic ...
A man with pellagra, which is caused by a chronic lack of vitamin B 3 in the diet. Severe deficiency of niacin in the diet causes the disease pellagra, characterized by diarrhea, sun-sensitive dermatitis involving hyperpigmentation and thickening of the skin (see image), inflammation of the mouth and tongue, delirium, dementia, and if left untreated, death. [7]
The niacin test has been widely used since the 1960s to identify mycobacteria at the species level in the clinical laboratory. [1] The niacin test detects niacin (nicotinic acid) in aqueous extracts of a culture. M. tuberculosis strains that test negative for the niacin test are very rare. [2]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
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The Joint Committee for Traceability in Laboratory Medicine or JCTLM is collaboration between the International Bureau of Weights and Measures (BIPM), the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), and the International Laboratory Accreditation Cooperation (ILAC).