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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These WHO interim recommendations for use of the Sinovac-CoronaVac were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been updat...ed: version 15 March 2022.
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7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...ion’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
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This summary assesses the current state of evidence on each approach in tabular form, providing: the definition and objectives; evidence of effectiveness; operational considerations (e.g., training, staffing, and logistics); cost considerations and evidence on cost-effectiveness; operational success...es and challenges; and areas for future research and learning. This document is not intended to endorse any particular approach. Rather, it aims to objectively present the state of the existing evidence on each approach, so as to inform decision-making among practitioners looking to further test, refine and implement such approaches.
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People-centered approaches that help communities maintain protective behaviours and follow guidelines set out by public health and government agencies are more important than ever. The evidence is clear, communities play a role in preventing and controlling epidemics and they are best able to take a...ction and slow or stop the spread of disease when properly engaged and empowered. This toolbox in 2 parts offers best practice approaches to community engagement with families. Promoting individual and joint responsibilities for the safety of the family, this toolbox aims to bring families and households together to manage shared risks and agree to safe behaviours critical for their safety and the safety of their community.
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Community-based interventions are vital for facilitating poststroke recovery, increasing community participation, and raising awareness about stroke survivors. To optimize recovery and community reintegration, there is a need to understand research findings on community-based interventions that focu...s on stroke survivors and their caregivers. Although nurses and community health workers (CHWs) are commonly involved in community-based interventions, less is known about their roles relative to other poststroke rehabilitation professionals (physical therapists, occupational therapists, and speech-language pathologists). Thus, the purpose of this review is to explore research focused on improving community-based stroke recovery for adult stroke survivors, caregivers, or both when delivered by nurses or CHWs.
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The Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, presents evidence-
based recommendations on the preferred methods for cleaning, disinfection and sterilization of patient-
care medical devices and for cleaning and disinfecting the healthcare environment. This docume...nt
supercedes the relevant sections contained in the 1985 Centers for Disease Control (CDC) Guideline for
Handwashing and Environmental Control. 1 Because maximum effectiveness from disinfection and
sterilization results from first cleaning and removing organic and inorganic materials, this document also
reviews cleaning methods. The chemical disinfectants discussed for patient-care equipment include
alcohols, glutaraldehyde, formaldehyde, hydrogen peroxide, iodophors, ortho-phthalaldehyde, peracetic
acid, phenolics, quaternary ammonium compounds, and chlorine. The choice of disinfectant,
concentration, and exposure time is based on the risk for infection associated with use of the equipment
and other factors discussed in this guideline. The sterilization methods discussed include steam
sterilization, ethylene oxide (ETO), hydrogen peroxide gas plasma, and liquid peracetic acid. When
properly used, these cleaning, disinfection, and sterilization processes can reduce the risk for infection
associated with use of invasive and noninvasive medical and surgical devices. However, for these
processes to be effective, health-care workers should adhere strictly to the cleaning, disinfection, and
sterilization recommendations in this document and to instructions on product labels.
LAST UPDATE 2019
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Access to medical personal protective equipment (PPE) is essential for routine healthcare delivery, and a critical tool for containing outbreaks, as well as preventing and responding to pandemics. It is one of our most effective tools against COVID-19, and an undervalued tool more generally in infec...tion control.
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Tackling COVID-19 misinformation. Ensuring communities have access to lifesaving public health information from trusted sources and are not misled by misinformation is essential to ending the COVID-19 pandemic.
In an effort to empower doctors and nurses – some of the most effective and trusted... messengers of public health information – to actively address COVID-19 misinformation and build vaccine confidence globally, the WHO welcomes this social media toolkit for healthcare practitioners, developed by the Government of the United Kingdom.
This toolkit aims to provide healthcare workers with the tools, skills and content needed to effectively share authentic and reliable information online. Centered around three core vaccine confidence messages, Vaccine Safety, Vaccine Development and Vaccine Reducing Risk of Sickness; this toolkit sets out three approaches: creating your own posts, posting the images and videos provided in the toolkit, or resharing vaccine information from trusted sources.
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This document aims to describe a minimum set of surveillance activities recommended at the national level to detect and monitor the relative prevalence of SARS-CoV-2 variants and outline a set of activities for the characterization and assessment of risk posed by these variants. A set of indicators ...is also provided to standardize monitoring and public reporting of variant circulation.
The document is primarily intended for national and sub-national public health authorities and partners who support implementation of surveillance for SARS-CoV-2 variants
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orientations provisoires, 14 juin 2021
Countries across the world are facing diverse epidemiological situations with varying response
capacities and access to life saving tools. The World Health Organization (WHO) recommends that national authorities continue to apply a risk-based approach when implementing measures related to COVID-19... and international travel while respecting the dignity, human rights and fundamental freedoms of travellers. This approach should consider the risk posed by travel for the importation and exportation of cases in the context of the evolving epidemiology, including the emergence and circulation of virus variants of concern; the expansion of the COVID-19 vaccination roll-out; and lessons learned while responding to the pandemic, including on the early detection and management of cases and the application of public health and social measures.
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временное руководство. Первый выпуск: 10 февраля 2021 г. Обновлено: 21 апреля 2021 г. Последнее обновление 30 июля 2021г.
24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, th...e Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ...[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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A series of data syntheses from the RCCE Collective Service. It focuses on public perceptions of the COVID-19 vaccinations, bringing together 66 data sources from quantitative surveys across 107 countries and six regions, underpinned by a rapid review of additional studies and community feedback dat...a from Africa.
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These WHO interim recommendations for use of the BBV152 COVAXIN vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been ...updated: version 15 March 2022.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
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Drug Distribution and Control: Preparation and Handling–Guidelines
Review 2008