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 field guide is designed for use by FHI 360 staff and partner organizations responsible for ensuring quality clinical services, at both facility and non-facility levels. The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement cl...inical facility and service assessments.
The accompanying checklists are intended to be used with the clinical facility assessment guide.
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QualityRights is WHO’s global initiative to improve the quality of care provided by mental health services and promote the human rights of people with psychosocial, intellectual and cognitive disabilities1. It offers a new approach to mental health care which is rights-based and recovery-oriented.
Assessing and improving quality and human rights in mental health and social care facilites
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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Antimicrobial resistance has become a serious public health threat for effective treatment of an ever increasing range of infections caused by bacteria, parasites, viruses and fungi. When infections can no longer be treated by first-line antibiotics, other antibiotics must be used, which are both mo...re expensive and more toxic. Treatment and hospitalization is prolonged, and patients undergoing operations and other medical procedures are more vulnerable to infections. All this imposes a huge burden on health care systems and on the economy of countries. This is a major challenge to the health system in Mauritius which provides health care free of user cost to the whole 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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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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Consistent, current and complete documentation in the medical record is an essential component of quality patient care. The following 21 elements reflect a set of commonly accepted standards for medical record documentation. An organization may use these elements to develop standards for medical rec...ord documentation. NCQA considers 6 of the 21 elements as core components to medical record documentation. Core elements are indicated by an asterisk (*).
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This standard Operating procedure (SOP) for JDWNRH is intended to describe and
address various important areas like admission procedure, on call process of the
doctors, interdepartmental consultation, patient discharge process and verity of
other areas which was so far solely based on verbal i...nstruction in the workplace by
the seniors which very often led to mishaps and other associate problems. This SOP,
though not comprehensive, would serve as a guidebook for newly recruited health
staff as well as a reference book for existing health professionals in JDWNRH while
delivering health care services
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Quality of Life for Children with Cancer Series: Modules on Paediatric Palliative Care. Module 7: Spirituality
What have we learned about air pollution and COVID-19? Learn about six air pollutants that are harming your health. Dr Maria Neira explains findings from WHO’s new air quality guidelines in Science in 5.
To improve the quality of care during labour and childbirth, facilitate effective implementation of the World Health Organization (WHO) recommendations: Intrapartum care for a positive childbirth experience, published in 2018, and promote a shift towards improving the experience of childbirth, WHO d...eveloped the WHO Labour Care Guide (LCG) and an accompanying WHO labour care guide: user's manual. The WHO LCG is a tool to facilitate implementation of quality, evidence-based, woman-centred care for a positive childbirth experience within the context of a broader, rights-based approach.
The goal of this policy brief is to provide maternal and newborn health stakeholders and decision-makers with an overview of the WHO LCG and its guiding principles, key advantages of making the shift from the WHO partograph to the WHO LCG, and what is required to ensure an enabling environment that will facilitate a sustainable introduction of the WHO LCG.
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Based on categories related to structure, content, language, and illustrations, the present study provides an evaluation of the quality of educational materials on leishmaniasis available to health services in Brazil. The 18 publications evaluated consisted of four handbooks, four guided studies, fo...ur booklets, and six leaflets. Of the total publications assessed, nine were produced by the Brazilian National Health Foundation (FUNASA), five by State and Municipal Health Departments jointly with FUNASA, and one by the Pan-American Health Organization. The evaluations were also performed by three professionals: a physician specialized in leishmaniasis, a parasitologist, and an information/communications expert. The publications failed to specify key items such as target public, objective, and bibliography. The illustrations, especially in the booklets and leaflets, failed to clarify the text, portrayed biased concepts, and omitted credits and scale. According to this study, informative materials on leishmaniasis distributed in Brazil present major limitations which jeopardize the quality of information they contain.
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This document summarizes several air quality measurement and modelling methods that can be used to estimate ground-level air pollutant concentrations and presents multiple approaches to monitoring ambient air pollution at different spatial and temporal scales. These methods are crucial for estimatin...g population exposures, which can be defined as the product of the pollutant concentration and the time over which a person is in contact with this pollutant.
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WHO Air Quality Guidelines set goals to protect millions of lives from air pollution
For the past 10 years, the EU Ambient Air Quality Directives have been an essential tool to drive
action against air pollution.
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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