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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety,
...
quality and efficacy of medicines.
more
The standards of care for HIV define the expected or desired quality of prevention, treatment, and care for people at risk of HIV acquisition or living with HIV.
The standards are based on a scientific rationale, as well as the responsibilities of
...
each stakeholder, to ensure that people receive appropriate, high-quality prevention and care that aligns with the most up-to-date medical knowledge and ethical standards
more
Mpox Molecular Diagnostic Tests(RT-PCR)
recommended
March 2025. Access to appropriate, quality-assured diagnostics remains a challenge. There is limited information on key characteristics of available test kits, including their performance, reliability, and ability to detect relevant Mpox clades. Add
...
itionally, the lack of multiplex diagnostic tools capable of distinguishing Mpox from other pathogens with similar clinical presentations further complicates case detection and response efforts.
more
The Pocket Guide to Managing Contraceptive Supplies addresses one of
the most important components of any program that provides family
planning services—the logistics system that manages the delivery,
quality, and storage of contraceptive suppl
...
ies. These supplies are
essential; without them, family planning services cannot be provided.
This guide is for the staff of family planning or health clinics who
manage contraceptive supplies and for the supervisor who oversees
these logistics activities. This booklet is not a complete logistics text;
its purpose is to be a quick reference for logistics formulas and
principles to help you manage your supplies (both contraceptives and
other commodities) correctly and efficiently.
more
Veterinarians are leaders and stewards in preserving the effectiveness of antibiotics for animals and people. Working with animal owners and producers, veterinarians can slow antibiotic resistance by implementing disease prevention strategies and improving the use of antibiotics while also guarante
...
eing high-quality medical care for animal patients.
more
This Cardiac Rehabilitation Change Package was completed by the Centers for Disease Control and Prevention (CDC) in collaboration with the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) with the purpose of helping cardi
...
ac rehabilitation programs, hospital quality improvement teams, and public health professionals who partner with these groups to implement systems and strategies that improve care for patients who are eligible for cardiac rehabilitation. AACVPR is a multidisciplinary professional association comprised of health professionals who serve in the field of cardiac and pulmonary rehabilitation.
more
A key component of elimination is to reduce the number
of unmanaged trachomatous trichiasis cases to less than
1 per 1,000 population in affected areas. This will require
not only a large increase in the number of surgeries
performed, but also improvements in the
...
quality of surgery
and in the efficiency of surgery provision programs. It also
will require that we make special efforts to reach out to
women and the most marginalized populations, who are
disproportionally affected by trichiasis (TT).
more
The document provides a standardized protocol for evaluating the Early Warning Alert and Response Network (EWARN), a surveillance system used during humanitarian emergencies when regular national health surveillance may be disrupted. The purpose of EWARN is to detect outbreaks of communicable diseas
...
es early and enable rapid public health response. The guidance explains how the system should be assessed in terms of its structure, implementation, effectiveness, and usefulness. It outlines the key steps of evaluation: preparation, system description, data collection, and post-evaluation reporting. The protocol highlights common challenges observed in previous EWARN implementations, such as delays in establishing the system, limited data quality, weak outbreak response, and lack of clear transition plans back to routine surveillance systems. It emphasizes the need to evaluate both weekly disease reporting and alert verification processes, and to review attributes such as simplicity, data quality, timeliness, sensitivity, and stability. The document also provides templates for interviews, data review forms, and laboratory assessment, as well as guidance on conducting remote evaluations when access is limited. The overall goal of the protocol is to ensure that EWARN functions effectively to detect and respond to outbreaks and that practical recommendations are developed to improve the system’s performance and sustainability in emergency settings.
more
The importance of robust mortality surveillance systems cannot be overstated in an era marked by increasing global health challenges where health threats loom large and population dynamics continue to evolve. Accurate and timely mortality data is essential for identifying trends and detecting emergi
...
ng health threats, evaluating the impact of interventions, and guiding evidence-based policy decisions.
This framework outlines a holistic approach to strengthening routine mortality surveillance systems, considering the unique contextual factors and challenges faced by African countries. It emphasizes the importance of establishing efficient data collection mechanisms, enhancing data quality and completeness, and promoting data sharing and collaboration among stakeholders.
Moreover, the framework recognizes the pivotal role of technology in the integration of data from fragmented mortality data sources. It highlights the potential of innovative data capture methods, advanced analytics, and real-time reporting systems to enhance mortality data’s accuracy, efficiency, and timeliness.
The continental framework for mortality surveillance aligns with Africa CDC’s mission and strategic goal by serving as a fundamental component in strengthening public health systems, enhancing disease surveillance capacities and capabilities, informing evidence-based policies and interventions, and promoting collaboration and coordination among African countries to address health challenges and improve health outcomes on the continent.
The successful implementation of this framework requires collective commitment and concerted efforts from governments, health institutions, and the international community. We hope this document will serve as a catalyst for transformative change, enabling countries to build resilient mortality surveillance systems that protect public health, save lives, and contribute to evidence-based decision-making.
more
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat
...
ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
more
Tutorial of local production of alcohol-based solution (WHO formulation)
WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed
WHO Collaborating Centre of Patient Safety Infection Control & Improving Practices; Hôpitaux Universitaires de Genève (HUG); Pharm-Ed
(2016)
C2
14.04.2016
Pharm -Ed
--
The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man
...
ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
more
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assuran
...
ce Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to provide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
more
This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The
...
Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
more
27 May 2021
This is a document to support the use of pulse oximeter for assessment of suspected and confirmed cases of Covid-19 in the community.
It is a well-known fact that Covid-19 can present as “happy hypoxia” with minimum symptoms of severe respiratory distress despite significant low ox
...
ygen levels in the blood. The use of pulse oximeter for clinical assessment significantly augments decision making, save lives and provide high quality care. It allows for early detection of patients with hypoxia requiring either close monitoring in the community or timely referral for hospital care.
more
Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services
...
at the facility and community levels in 10 districts, covering nearly a third of the country.
Our team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
more
The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medic
...
ines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
more
Decontamination of medical devices plays an important role in the prevention of health care-associated infections. It includes cleaning, disinfection and/or sterilization. The processes involved in decontamination are complex, require specific infrastructure and equipment, and involve several sequen
...
tial steps that need to be performed correctly – from device collection and receipt by the decontamination unit to processing, storage and distribution throughout the facility. Quality control procedures (such as validation) at each step of the decontamination process are of the utmost importance to ensure the correct functioning of the equipment and processes. This aide-memoire presents a concise overview of important advice and key elements at a glance.
more
Based on scientific evidence, expert consensus and country experiences, the WHO core components for infection prevention and control (IPC) are the foundation for establishing or strengthening effective programmes at the national and facility level.
...
These new guidelines on core components of infection prevention and control (IPC) at the national and acute health care facility level will enhance the capacity of Member States to develop and implement effective technical and behaviour modifying interventions. They form a key part of WHO strategies to prevent current and future threats from infectious diseases such as Ebola, strengthen health service resilience, help combat antimicrobial resistance (AMR) and improve the overall quality of health care delivery. They are also intended to support countries in the development of their own national protocols for IPC and AMR action plans and to support health care facilities as they develop or strengthen their own approaches to IPC.
more
Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guide
...
lines therefore is to assist pharmacists in discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
more
Control of pollution from antibiotic manufacturing is a key part of safeguarding the longevity of antibiotics for all. Pollution contributes to antibiotic resistance and potentially undermines the effectiveness of medicines. High levels of antibioti
...
cs in water bodies downstream of manufacturing sites have been widely documented. Currently, antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.
more
