Health products policy and standards - World Health Organization …
Good 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 ...
TRS 986 - Annex 2: WHO good manufacturing practices for …
Oct 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 ...
The 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).
Medicines: Good manufacturing practices - World Health Organization …
Nov 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.
The 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.
good manufacturing practices (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.
good 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.
A WHO guide to good manufacturing practice (GMP) requirements ...
A WHO guide to good manufacturing practice (GMP) requirements / written by Gillian Chaloner-Larsson, Roger Anderson, Anik Egan; in collaboration with Manoel Antonio da Fonseca Costa Filho, Jorge F. Gomez Herrera.
Health products policy and standards - World Health Organization …
Oct 31, 2022 · WHO good manufacturing practices. Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
WHO 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-