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.
PQDx 0181-031-00
WHO PQ Public Report
March/2017, version 3.0
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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WHO, in partnership with the International Society for Prosthetics and Orthotics (ISPO) and the United States Agency for International Development (USAID), has published global standards for prosthetics and orthotics. Its aim is to ensure that prosthetics and orthotics services are people-centred an...d responsive to every individual’s personal and environmental needs. The standards advocate for the integration of prosthetics and orthotics services into health services, under universal health coverage. Implementation of these standards will support countries to fulfil their obligations under the Convention on the Rights of Persons with Disabilities and towards the Sustainable Development Goals, in particular Goal 3: Ensure healthy lives and promote well-being for all at all ages.
The standards provide guidance on the development of national policies, plans and programmes for prosthetics and orthotics services of the highest standard. The standards are divided into two documents: the standards and an implementation manual. Both documents cover four areas of the health system:
policy (governance, financing and information);
products (prostheses and orthoses);
personnel (workforce);
and provision of services.
The Standards have been developed through consultation with experts from around the globe via a steering group, development group and external review group.
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USAID/KENYA Evaluation Services and Program Support (ESPS)
The United States Agency for International Development (USAID) has a solid track record of supporting health and development initiatives in Kenya. AIDS, Population, and Health Integrated Assistance (APHIA) is the agency’s flagship hea...lth initiative in the country. APHIA is currently in its third iteration, APHIAPlus, which began in January 2011 and is slated to end in December 2015. APHIAPlus was designed to contribute to Result 3 (“Increased use of quality health services, products, and information”) and Result 4 (“Social determinants of health”) of USAID/Kenya’s implementation framework. The main technical areas of focus are HIV/AIDS; malaria; family planning (FP); tuberculosis (TB); maternal, newborn, and child health (MNCH); and water, sanitation, and hygiene (WASH).
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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 European Office for the Prevention and Control of Noncommunicable Diseases organized an expert meeting on monitoring of digital marketing of unhealthy products to children and adolescents in June 2018. Based on that meeting, this report aims to provide a tool to support Member States in moni...toring digital marketing of unhealthy products to children; the resulting tool – the so-called CLICK monitoring framework – is flexible and can be adapted to national context. The report also describes current digital marketing strategies, the challenges arising from current practices, and some policy options to tackle digital marketing to children and adolescents.
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Working Document Nov. 2020
The COVAX Supply and Logistics workstream lead by UNICEF, Gavi and WHO have released a working copy of the COVID-19 Vaccination, Country Readiness & Delivery: Supply and Logistics Guidance. Countries might find this Guide useful when developing and strengthening their sup...ply chain strategies to receive, store, distribute and manage the COVID-19 vaccines and their ancillary products, in line with their national deployment and vaccination plan (NDVP). The document also provides links to the different tools and resources to aid countries in performing assessment, planning and capacity-building activities.
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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 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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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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The Abuja declaration identifies that the prevention and control of HIV/AIDS, tuberculosis and related infectious diseases must come with additional financial resources. Therefore, African governments agreed on setting the target of allocating at least 15 per cent of each country’s annual budget ...to the improvement of the health sector. Moreover, the declaration demands donor countries to assist by fulfilling the target of delivering official development assistance (ODA) in the amount of 0.7 per cent of gross national product (GNP).
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The environment in which young people live, learn and play significantly affects their decisions about whether to consume alcohol. Environmental factors are the main risk factors driving alcohol consumption and related harm among young people. Environments that normalize alcohol consumption – term...ed alcogenic environments – include contexts with unregulated advertising and marketing of alcoholic beverages, higher alcohol outlet density, products designed to facilitate affordability and low prices of alcoholic beverages. A recent body of research evidence has emerged related to the measurement, functional significance and consequences of living in alcogenic environments. This includes findings on the complex and bidirectional interactions among alcohol acceptability, availability and affordability and how they create and perpetuate alcogenic environments. Comprehensive and enforced alcohol control policies are effective at delaying the age of onset and lowering alcohol prevalence and frequency among young people. Evidence consistently confirms the effectiveness of designing and implementing alcohol control policies that regulate upstream the drivers of alcogenic environment, including alcohol availability, acceptability and affordability. These policies need to be multipronged and address the complex interactions between these drivers and the local alcohol culture
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Access to safe blood and blood products is recognized as one of the key requirements for delivery of modern health care in the journey towards health for all. The foundation of safe and sustainable blood supplies depends on the collection of blood from voluntary non-remunerated and low-risk donors. ...Data from the WHO Global Database for Blood Safety (GDBS) brings out several inadequacies related to the supply and safety of blood and blood products. These inadequacies include a number of variations in safe blood practices across the world, including the quantity of blood donated (voluntary and replacement types), quality and adequate testing of the donated blood (immunohaematology [IH] and transfusion-transmitted infections [TTIs]), rational use of blood and blood components such as appropriate patient blood management protocols. These variations are very high in countries of the South-East Asian Region and most of them are either low- or middle-income countries (LMICs).
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This document highlights landmarks and key milestones in the development and implementation of the global agenda for noncommunicable diseases (NCDs) over the last two decades. It summarizes where the world was in 2000, where it is in 2022, and where the world wants to be in terms of NCD prevention a...nd control by 2030. It recalls the commitments made by heads of state and governments, and outlines the technical guidance provided by the World Health Organization (WHO) in support of national efforts to achieve the internationally agreed NCD targets for 2025 and 2030.
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