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 specification.

Oct 1, 2014 · This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of …

ularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a b.

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.

Practices (GMP) of the World Health Organization (WHO). The WHO GMP publi-cations, other GMP Regulations/Guidelines and many publications on the concept and process of validation for pharmaceutical manufacture were consulted during prepara-tion of the Guide. These references are listed in Appendix 3. The emphasis in this

For the purposes of this guide, the terms “current good manufacturing practices” and “good manufacturing practices” are equivalent. The guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment.

Premises, equipment and process should be appropriately designed, qualified and validated and, where applicable, be subjected to ongoing verification according to the relevant sections of the good manufacturing practices (GMP) guide.

Aug 19, 2016 · Guidelines published by WHO are intended to be scientific and advisory in nature. Each of the following sections constitutes guidance for national regulatory authorities (NRAs) and for manufacturers of biological products.

GMP documents, the WHO GMP guidelines (ref 27) present the principles of QA are to ensure that GMP and other regulatory codes (GLP - Good Laboratory Practice, and GCP - Good Clinical Practice) are respected; that responsibilities are clearly speci-

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. World Health Organization. https://iris.who.int/handle/10665/64465. 2pts. in 2v.