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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”.
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Operational guidance for managing programme quality.
These guidelines are about implementing the programme-quality standards of the Core Humanitarian Standard in limited access humanitarian response. They have been developed using approaches and tools tested by Oxfam, other INGOs and the UN in Afgh
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anistan, DRC, Iraq, Somalia, Syria and Yemen. The guidelines are an operational resource to help programme designers and decision makers deliver ‘good enough’ programme quality in limited access humanitarian response.
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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.
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This manual has been designed to be used in conjunction with two earlier WHO publications, "Basic tests for pharmaceutical substances" (1986) and "Basic tests for pharmaceutical dosage forms" (1991). Most of the pharmaceutical substances and dosage forms covered are included in the WHO Model List of
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Essential Drugs. The present volume describes procedures for testing a further 23 pharmaceutical substances and 58 pharmaceutical dosage forms and also for testing 4 medicinal plant materials.
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Health facilities in the Region of the Americas frequently suffer the effects of health emergencies and disasters, which jeopardize their ability to provide services to the population. The STAR-H methodology helps staff responsible for health emergency and disaster risk management to identify and as
...
sess risks as part of strategic planning to improve facility preparedness. It is intended to help them develop, with a multi-hazard approach, a response framework with operating procedures to deal with hazards of any type, scale, or frequency; determine roles and responsibilities; facilitate the effective use of resources; undertake strategic planning exercises, and improve the preparedness of facilities to effectively respond to and recover from impacts. This methodology is designed for use in health facilities of any size and capacity, and makes it possible to generate historical reports and national or subnational risk profiles. This information can be used to develop an effective health emergency and disaster risk management program.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i
...
nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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Revision Bulletin ESPNF
GPHF-Minilab: Manuals
recommended
GPHF Minilab manuals on basic dye and thin layer chromatographic testing. The newest version of the manual (Volume I + II) from 2008 is available in three languages: English, French, Spanish. Combining the main manual with the supplements issued each year between 2010 and 2015, label claims on drug
...
identity and content can now be verified for 75 active ingredients and their fixed-dose combination products using simple, rapid and affordable thin layer chromatographic tests. Please note: Only the demo versions are online available!! The complete manuals are only available after purchasing the Minilab!
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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,
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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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The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and
...
its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels. more
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels. more
La fourniture de sang et de produits sanguins sûrs et efficaces pour la transfusion ou la fabrication d’autres produits sanguins fait intervenir un certain nombre de processus, allant de la sélection des donneurs de sang et de la collecte, au traitement et au dépistage des dons de sang ainsi qu
...
’à l’analyse des échantillons des malades, à la délivrance de sang compatible et à son administration au patient. Il existe un risque d’erreur à chaque étape de la « chaîne de transfusion », et une défaillance à une quelconque de ces étapes peut avoir des conséquences graves pour les receveurs du sang ou des produits sanguins. Si la transfusion sanguine peut sauver des vies, elle comporte aussi des risques, en particulier la transmission des infections par le sang.
Le dépistage des infections transmissibles par transfusion (ITT) en vue d’exclure les dons de sang présentant un risque de transmettre une infection du donneur aux receveurs est une étape critique du processus visant à garantir au mieux la sécurité des transfusions. Un dépistage efficace des agents transmissibles par le sang les plus courants et les plus dangereux peut réduire le risque de transmission à des niveaux très faibles. more
Le dépistage des infections transmissibles par transfusion (ITT) en vue d’exclure les dons de sang présentant un risque de transmettre une infection du donneur aux receveurs est une étape critique du processus visant à garantir au mieux la sécurité des transfusions. Un dépistage efficace des agents transmissibles par le sang les plus courants et les plus dangereux peut réduire le risque de transmission à des niveaux très faibles. more
External quality assessment (EQA) is an important component of quality systems for blood transfusion services. Establishing external quality assessment programmes for screening of donated blood for transfusion-transmissible infections (TTI): implementation guide aims to support WHO member States in
...
establishing and operating EQA programmes for screening donated blood for TTI. The guides has been designed for use by national health authorities and EQA organizing institutions in the development of EQA programme. It will also give participating laboratories an insight into the organization of EQA programmes for TTI screening and an understanding of the benefits of participation.
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Laboratory Biossafety Manual
L’évaluation externe de la qualité (EEQ) est une composante importante des systèmes qualité des services de transfusion sanguine. L’EEQ est l’évaluation externe de la qualité générale des résultats obtenus par un laboratoire dans l’analyse d’échantillons de contrôle dont le cont
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enu est connu, mais n’a pas été dévoilé, et la comparaison de ces résultats avec ceux qu’ont obtenus d’autres laboratoires qui ont analysé les mêmes échantillons. Dans les laboratoires qui pratiquent le dépistage des infections transmissibles par transfusion (ITT) dans les dons de sang, la participation à l’EEQ aide à surveiller et améliorer la qualité des résultats. Les informations issues de l’EEQ permettent d’améliorer continuellement la qualité en mettant en évidence les erreurs d’un laboratoire et d’appliquer des mesures pour éviter qu’elles se reproduisent. L’EEQ joue ainsi un rôle essentiel dans l’amélioration de la sécurité transfusionnelle.
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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
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
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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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This checklist covers five areas of competence needed by health care providers to provide quality of care in contraceptive information and services including: respecting users’ privacy and guaranteeing contfidentiality, choice, accessible and acceptable services, involvement of users in improving
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services and fostering continuity of care and follow-up.
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The aim of this guidance manual is to introduce the user to project/programme plan- ning in a Red Cross Red Crescent environment. It describes the different stages of the planning phase of the “project/programme cycle” within the context of Results-Based Management (RBM). It also gives an overvi
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ew of the various components of RBM and explains how to integrate and apply this approach in practice. In addition, the manual summarizes briefly the other key phases of the cycle (assessment, imple- mentation and monitoring, evaluation) and provides references to the key Federation manuals on these phases.
The manual has been developed primarily for use by people managing projects and programmes either in a National Society or the secretariat of the International Federation of Red Cross and Red Crescent Societies (International Federation). Although it is mainly designed for use at the country level, the basic principles can be applied to project and programme planning at any level. The manual draws on two International Red Cross and Red Crescent Movement publications – the International Federation’s Project Planning Process (2002) and the ICRC Economic Security Unit’s Programme/ Project Management: The Results-Based Approach (2008) – reflecting the significant similarity of approach. The International Federation has developed the manual internally to suit the particular needs and uses of project/programme management within the organization.
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Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
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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
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ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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Laboratory Biossafety Manual
