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The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Good Clinical Laboratory Practice (GCLP) Guideline [ edit ] The GCLP guidelines was originally produced in 2002 by RQA committee members with the purpose of providing guidance on the quality system required in laboratories that undertake the analysis of samples from clinical trials.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries , for example good agricultural practice , or GAP.
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.
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
Good laboratory practice 24. Medicinal products for human use 25. Medicine prices 26. Nutrition health claims, composition and labelling 27. Blood safety and quality 28. Organs 29. Public health (serious cross-border threats to health) (notification system for pandemic flu, Zika etc.) 30. Tissues and cells (apart from embryos and gametes) GEO 31.
The CDC Good laboratory practice guidelines for newborn screening recommends that "laboratory specimen retention procedures should be consistent with patient decisions." [49] Researchers have described the NBS samples as a gold mine representing a patient population that would otherwise be impossible to get. [46]
The proposal was endorsed by health care agencies from all parts of the world such as AHRQ (USA), CBO (NL) German Agency for Quality in Medicine, NICE (UK), SIGN (UK), and NZGG (NZ). Against this background the Guidelines International Network GIN was founded in November 2002 in Paris with Günter Ollenschläger as founding chairman. [5]