Over the past few decades and throughout the world, the landscape of adolescent health has been altered dramatically. Currently, the total population of adolescents between the ages of 10 and 19 years is 1.2 billion – the largest generation of young people in history. The vast majority of adolesce...nts (85%) live in developing countries where, in many areas, they make up more than a third of the population. They face a variety of different experiences given the diverse political, economic, social and cultural realities within their communities. Although, for many, adolescence is a period of learning and building confidence in a nurturing environment, for others it is a period of heightened risk and complex challenges.
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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.
This compendium collates current tools and resources on quality improvement developed by the WHO Service Delivery and Safety Department and provides examples of how the tools and resources have been applied in country settings. The target audience for this document are ministries of health, facility... quality improvement teams, researchers and development agencies. WHO technical programmes, regional and country offices can also use the document in their technical cooperation work with the identified audience. Those working to improve the quality of health service delivery can also make good use of this resource
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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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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.
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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 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.
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The WHO Quality Health Services: a planning guide focuses on actions required at the national, district and facility levels to enhance quality of health services, providing guidance on implementing key activities at each of these three levels. It highlights the need for a health systems approach to ...enhance quality of care, with a common understanding on the activities needed by all stakeholders. The guide articulates the key actions required to improve the quality of health services for the entire population. It recognizes that the path varies for each country, district and facility – stimulating the reader to consider multiple factors and entry points for action. This planning guide is for staff working at all levels of the health system (i.e. national, district and facility) who have a role in enhancing the quality of health services. It is also relevant to all stakeholders initiating and supporting action at facility, district and/or national levels both in the public and private sectors.
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In fragile, conflict-affected and vulnerable settings, delivery of quality health services faces significant challenges, including disruption of a routine health service organization and delivery systems, increased health needs, complex and unpredictable resourcing issues, and vulnerability to multi...ple public health crises. Despite the difficulty of addressing quality in such settings, the necessity for action is acute, given the significant health needs of the populations in these environments and the increasing numbers of people for whom such settings are home.
This manual has been developed to provide a starting point for multi-actor efforts and actions to address quality of care in the most challenging settings. This includes practical approaches to action planning and implementation of a contextualised set of quality interventions.
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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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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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Laboratory Biossafety Manual
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.
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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The HHFA Comprehensive guide serves as the main reference document for planning and implementing a country HHFA. This guide will promote understanding of:
What the HHFA is and the information it can and cannot provide.
The HHFA modules, questionnaires and CSPro electronic data collection tool.
Th...e HHFA indicators, indices and their organization within the HHFA indicator inventory platform.
The HHFA data analysis platform.
The HHFA sampling and data collection methodologies.
The detailed steps involved in planning and implementing an HHFA.
Key concepts in review, interpretation and communication of HHFA findings.
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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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Adolescence is a critical stage in life for physical, cognitive and emotional development, shaping future health and well-being. Comprehensive measurement of adolescent health is essential to prioritize health issues, guide interventions and track progress. However, global, regional and national ado...lescent health measurement has historically been inconsistent and incomplete.
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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi...on, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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Providing quality, stigma-free services is essential to equitable health care for all and achieving global HIV goals and broader Sustainable Development Goals related to health. Every person has the right to the highest attainable standard of physical and mental health. Countries have a legal obliga...tion to develop and implement legislation and policies that guarantee universal access to quality health services and address the root causes of health disparities, including poverty, stigma and discrimination.
The health sector is uniquely placed to lead in addressing inequity, assuring safe personcentred care for everyone and improving social determinants of health by overcoming taboos and discriminatory or stigmatizing behaviours associated with HIV, viral hepatitis and sexually transmitted infections (STIs). Improving health care quality and reducing stigma work together to enhance health outcomes for people living with HIV. Together, they make health care services more accessible, trustworthy and supportive. This encourages early diagnosis, consistent treatment and improved mental well-being. Thus, people living with HIV are more likely to engage with and benefit from health care services, leading to improved overall health.
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