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This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient
...
selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
more
The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof
...
essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
more
Les déchets générés par les activités de soins de santé, depuis les aiguilles infectées jusqu'aux isotopes radioactifs, peuvent être source d'infection ou de blessures et leur gestion inadéquate peut avoir des conséquences sérieuses pour la santé publique et des effets délétères sur l
...
'environnement.
Ce document souligne les aspects clés de la gestion sécurisée des déchets médicaux afin de guider les décideurs politiques, les praticiens et les gestionnaires des centres afin d’améliorer ces services dans les établissements de santé. more
Ce document souligne les aspects clés de la gestion sécurisée des déchets médicaux afin de guider les décideurs politiques, les praticiens et les gestionnaires des centres afin d’améliorer ces services dans les établissements de santé. more
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
more
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in
...
1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
more
Revision Bulletin ESPNF
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u
...
se research.
Digital publication you can download the English, French, Spanish and Russian version
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
more
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o
...
ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
more
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
...
understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
more
Priorities for Tuberculosis Bacteriology Services in Low-Income Countries International Union
Hans L. Rieder, Armand Van Deun, Kai Man Kam, Sang Jae Kim, T. Martin Chonde, Arnaud Trébucq, Richard Urbanczik
International Union Against Tuberculosis and Lung Disease
(2007)
CC
Second Edition
Biorisk reduction combines expertise and advice on high consequence pathogens with guidance and training on safe handling and control of disease agents that pose significant health risks, with potential for adverse economic impact and public concern.
Biorisk management includes analysis of ways a
...
nd development of strategies to minimize the likelihood of the occurrence of biorisks. The goal of biorisk reduction is to ensure that current scientific knowledge regarding viral hemorrhagic fevers, epidemic-prone orthopoxviruses, and emerging severe zoonotic diseases affecting humans, is maintained in order to apply the most appropriate guidance for treatment, control, and safety to mitigate the risks regardless of the source of the disease event.
more
A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl
...
udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
more
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen tests in different transmission scenarios of t
...
he COVID-19 outbreak, including how testing might be rationalized in low resource settings. All testing should be followed by a strong public health response including isolating those who test positive and providing them care, contact tracing and quarantine of contacts.
more
Instruction for Use
orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépistage et à l'utilisation de la PCR et des tests an
...
tigéniques rapides dans différents scénarios de transmission de l'épidémie de COVID-19, y compris la manière dont les tests pourraient être rationalisés dans les milieux à faibles ressources. Tous les tests doivent être suivis d'une réponse de santé publique forte, comprenant l'isolement des personnes dont le test est positif et la fourniture de soins, la recherche des contacts et la mise en quarantaine des contacts.
more
