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Labbé, T.
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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,... 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...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...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 ...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...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...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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Laboratory Biossafety Manual
The objective of this course is to provide high-level information and contextual understanding of WHO Standard Operating Procedures (SOPs) for Emergencies.
We will explore a range of topics, ranging from the Emergency Response Framework (ERF), to planning, grants and finance, procurement, risk mana...gement, rosters and deployment, and ethics.
Each module within this course is standalone. Therefore, you can take the modules in any order – with the exception of the Course Review. The Course Review is a question-based revision module that recaps the content covered in modules 1 to 10.
The target audience for this course is personnel who will be assigned by WHO to go on deployment in response to health emergencies.
The course is available in English and French
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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WHO’s Country Cooperation Strategy (CCS) defines the Organization’s medium-term vision for working in and with a particular country. The CCS, developed in the context of global and national health priorities, examines the overall health situation in a country, including the state of the health s...ector, socioeconomic status and the major health determinants.
This CCS sets out WHO’s strategic framework for collaboration with the Syrian Arab Republic, from June 2022 until June 2025, in light of the 12 years of crisis that have had a devastating impact on the health sector and infrastructure of basic services. It carefully considers the current and projected issues during its transition from continued humanitarian assistance to recovery, resilience and development. The consolidation of health policies and strategies and health system strengthening, based on the strengthening of primary health care (PHC), aims to contribute to the achievement of national and global development and health goals and the targets of the SDGs.
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The key actions, activities, and approaches in this document are organized within each of the 5Cs (see Table 1 in the PDF) and those of the Strategic preparedness and response plan (SPRP) pillars as follows:
National action plan key activities, prioritized for the current context and the current ...understanding of the threat of SARS-CoV-2
A. Transition from emergency response to longer term COVID-19 disease management.
B. Integrate activities into routine systems.
C. Strengthen global health security.
Special considerations for fragile, conflict-affected and vulnerable (including humanitarian) settings
WHO global and regional support to Member States to implement their national action plans
Key guidance documents for reference
This is a living document that will be updated to incorporate new technical guidance in response to the evolving epidemiological situation. National plans should be implemented in accordance with the principles of inclusiveness, respect for human rights, and equity.
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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.
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