The 7th edition of the Orange Guide provides practical guidance to health workers on the front line of TB control. It includes sections on HIV, MDR-TB and a review of the recommended treatment regimens
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.
4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of flow cytometric immunophenotyping and will be of u...se to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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Senegal has adopted the World Health Organization–Joint United Nations Programme on HIV/AIDS recommended 90-90-90 targets.5 The adoption of this strategy means that the country is expected, by 2020, to have 90% of its population living with HIV diagnosed, 90% of all those diagnosed receiving susta...ined HIV treatment, and 90% of those receiving antiretroviral therapy having suppressed viral load measures.5 To achieve these outcomes, having good clinical laboratory services for diagnosis and follow-up will be critical.6 More specifically, investments will be needed to improve laboratory infrastructure, and to facilitate the access and availability of routine viral load and early infant diagnosis (EID) measures through the implementation of point-of-care (POC) diagnostic platforms along with an efficient and sustainable quality assurance programme.
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Handbook of COVID-19 Prevention and Treatment, expecting to share their invaluable practical advice and references with medical staff around the world. This handbook compared and analyzed the experience of other experts in China, and provides good reference to key departments such as hospital infect...ion management, nursing, and outpatient clinics. This handbook provides comprehensive guidelines and best practices by China's top experts for coping with COVID-19.
This handbook, provided by the First Affiliated Hospital of Zhejiang University, describes how organizations can minimize the cost while maximizing the effect of measures to manage and control the coronavirus outbreak. The handbook also discusses why hospitals and other healthcare institutions should have command centers when encountering a large-scale emergency in the context of COVID-19. This handbook also includes the following:
- Technical strategies for addressing issues during emergencies.
- Treatment methods to treat the critically ill.
- Efficient clinical decision-making support.
- Best practices for key departments like inflection management and outpatient clinics.
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23 March 2021
The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans.
Dr Montresor’s presentation highlighted that while there is currently no “gold standard” for the... diagnosis of S. stercoralis, there is a felt urgency to optimize diagnostic regimens that are currently available, and in the context of population-based testing (as opposed to individual focused diagnostics in clinical settings).
In other words, the diagnostic test(s) should have good accuracy, but we should remember that in public health we do not aim at individual diagnosis: rather, we need a tool that should help to estimate the prevalence in a population.
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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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July 2021. This publication brings together important clinical and programmatic updates produced by WHO since 2016 and provides comprehensive, evidence-informed recommendations and good practice statements within a public health, rights-based and person-centred approach.
These guidelines bring in... the most recent guidance on HIV testing strategies - the entry point for HIV prevention and treatment - and include comprehensive guidance on infant diagnosis. Key recommendations are presented on rapid antiretroviral therapy (ART) initiation and the use of dolutegravir. Updated recommendations are included on the timing of ART for people with TB, and the use of point-of-care technologies for treatment monitoring.
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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 guidelines 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.
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Technical guidelines for testing for COVID-19 in the clinical laboratories of the National Integrated Health System.
Most neglected tropical diseases (NTDs) occur in remote areas of low- and middle-income countries, where health systems are often poorly developed. Therefore, these neglected patients generally lack access to quality preventive, diagnostic, and therapeutic care [1]. The difficulty to access NTD-ende...mic areas, challenging logistics, and the lack of skilled human resources in these areas are also major obstacles to conduct clinical research. We had to face these when conducting a good clinical practice/good clinical laboratory practice (GCP/GCLP)-compliant clinical study in eastern Sudan, a well-known endemic area for visceral leishmaniasis and other NTDs. We share here the challenges related to study preparation and implementation of this GCP/GCLP study that investigated the causes of persistent fever in a rural hospital located in Gedaref State in eastern Sudan. We think this type of paper may be of interest for researchers planning to conduct a clinical trial in a resource-limited setting as well as for funders of such research.
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