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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.
The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control , in "runs" consisting of measurements of multiple samples.
Westgard rules are commonly used to analyse data in Shewhart control charts. Westgard rules are used to define specific performance limits for a particular assay (test) and can be used to detect both random and systematic errors. Westgard rules are programmed into automated analyzers to determine when an analytical run should be rejected. These ...
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.
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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]
Shirtless Man Pinned Flight Attendant Against ‘Aircraft Exit Door’ and Threatened Violence, Say Authorities
Kris Jenner is getting in the Christmas spirit with some sexy snaps. On Dec. 24, the famous momager, 69, shared a series of throwback pictures revealing her chic holiday style throughout the years ...