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Publication Years
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4
Information and Approaches for developing Country Settings
A model quality assurance system for procurement agencies
World Health Organization
World Health Organization, United Nations Children's Fund, United Nations Development Programme, United Nations Populations Fund, World Bank
(2007)
C_WHO
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut
...
ion of pharmaceutical products.
more
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
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
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
Revision Bulletin ESPNF
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
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.
more
Recommended measures for medical and other staff who were involved in patient care or outbreak response during the Ebola outbreak in 2014
Robert-Koch-Institut
(2014)
This document describes recommended measures for dealing with medical and other staff employed either in patient care or in outbreak control during the 2014 Ebola outbreak.
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
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
Interim Guidance 31 march 2020
WHO has established a shipment mechanism to expedite and cover the costs of the shipment of clinical samples from patients with suspected COVID-19 from the country of collection to one of the WHO reference laboratories providing confirmatory molecular testing for COVI
...
D-19. This document explains the process and documentation required for shipment of specimens.
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
The standard operating procedures (SOP) for referral care cover all the refugee populations living in Lebanon. These SOPs outline the policies and procedures for referral care in Lebanon, including the limits in health assistance that can be provided.
second edition
Zambia Report for 2017
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
