Health products policy and standards - World Health Organization …
WEBGood Manufacturing Practices. Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product ...
Medicines: Good manufacturing practices - World Health Organization …
WEBNov 20, 2015 · Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
TRS 986 - Annex 2: WHO good manufacturing practices for …
WEBOct 1, 2014 · Overview. Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the ...
WEBThe first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34).
WEBmanufacturing practices (GMP) guide. The use of appropriate technologies (such as restricted access barrier systems (RABS), isolators, robotic systems, rapid/alternative methods and continuous monitoring systems) should be considered to increase the protection of the product from potential sources of endotoxin/pyrogen,
WEBgood manufacturing practices (GMP) standards for medicinal gases are not followed, for example in the production and control of industrial oxygen, the purity and content of oxygen could be affected.
WEBThe Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies.
WEBWHO defines Good Manufacturing Practices (GMP) as “that part of quality assur-ance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authori-zation” (ref 27). GMP covers all aspects of the manufacturing process: defined manu-
A WHO guide to good manufacturing practice (GMP) …
WEBA WHO guide to good manufacturing practice (GMP) requirements. Pt. 3, Training. World Health Organization. https://iris.who.int/handle/10665/69396. Description. "This guide is the result of cooperation between many colleagues and institutions.
WHO launches Pharmaceutical Quality Assurance guidelines, 10th …
WEBFeb 29, 2024 · The compendium, developed for national regulatory authorities, pharmaceutical manufacturers, healthcare professionals, and procurement agencies, is instrumental in upholding the globally acceptable standards of good manufacturing practices (GMP) and inspections.
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