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 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 basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Technical and operational ‘how-to’: practical considerations
The handbook Global edition
Ce manuel a été conçu dans le but de fournir un matériel de référence complet sur le système de gestion de la qualité au laboratoire pour toutes les personnes intervenant dans les processus de laboratoire, tant au niveau de la gestion, de l’administration que du travail technique.
A Community Guide to Environmental Health > Chapter 19: Health Care Waste. Please download this chapter from the website of Hesperian
Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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Collaboration between The Lancet and Imperial College London, UK, has resulted in a new Commission, which examines how medical technology should best be used to improve health in low- and middle-income countries. The report concludes that in many cases, medical technology—almost exclusively develo...ped in rich countries—is simply inappropriate for use in poorer nations
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The PQS on-line catalogue includes details of all immunization-related products currently pre-qualified by WHO for procurement by United Nations agencies. The catalogue is produced and maintained by the Quality, Safety and Standards group in the Immunization, Vaccine and Biologicals Department of WH...O, Geneva. It replaces the old WHO/UNICEF Product Information Sheets (PIS), the last edition of which was published in 2000. Only products included in the PQS catalogue are now recommended to be purchased by UN agencies.
Large File: 120 MB
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This document provides an overview of the issues and challenges surrounding medical device donations, and offers considerations and best practices that may be useful for making and soliciting donations. The document highlights the importance of an active participatory role for the intended recipient...s of medical equipment donations and emphasizes the importance of treating donations with the same rigour typically applied when purchasing medical equipment.
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Médicaments et dispositifs médicaux pour une population de
10 000 personnes pendant environ 3 mois
"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to eng...age in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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