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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO
...
& international GMP standards, technological advancements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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
This document is part three in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. Part two focused on the ingredients in a vaccine and the three clinical trial phases.
This document outlines the
...
next part of the vaccine journey: the steps from completing the clinical trial phases through to distribution.
more
Manufacturing Facility Assessment Toolkit
recommended
Tools and resources for occupational safety and health professionals and state and local public health officials assessing manufacturing facilities.
Occupational safety and health professionals and state and local public health officials can use th
...
ese tools to assess coronavirus disease 2019 (COVID-19) infection prevention and control measures at manufacturing facilities, as well as these facilities’ overall hazard assessment and control plans
more
STATUTORY INSTRUMENTS | SUPPLEMENT No. 8 28th March, 2014 | STATUTORY INSTRUMENTS SUPPLEMENT | to The Uganda Gazette No. 18 Volume CVII dated 28th March, 2014 | Printed by UPPC, Entebbe, by Order of the Government. | STATUTORY INSTRUMENTS | 2014 No. 29.
A model quality assurance system for procurement agencies
World Health Organization
World Health Organization, United Nations Children's Fund, United Nations Development Programme, United Nations Populations Fund, World Bank
(2007)
C_WHO
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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Guidance for the preparation and submission of dossiers
Improvements in water sanitation and hygiene (WASH) and wastewater management in all sectors are critical elements of preventing infections and reducing the spread of antimicrobial resistance (AMR) as identified in the Global Action Plan to combat AMR. Yet, at present, WASH and wastewater management
...
actors and improvement actions are under-represented in AMR multi-stakeholder platforms and national action plans (NAPs). This WHO/FAO/OIE technical brief on WASH and wastewater management to reduce the spread of AMR provides a summary of evidence and rationale for WASH and wastewater actions within AMR NAPs and sector specific policy to combat AMR. Evidence and actions are presented in the domains of; coordination and leadership, households and communities, health care facilities, animal and plant production, manufacturing of antimicrobials, and surveillance and research.
more
Building on Nigeria’s Call to Action to Save Newborn Lives, the Federal Ministry of Health (FMoH) has developed the National Strategy and Implementation Plan for Scale-up of Chlorhexidine. The Ministry incorporated existing maternal, newborn, and child health plans with additional comprehensive st
...
rategic planning and consultation to develop a comprehensive, five-year costed scale-up plan. The strategy and implementation plan is intended to guide programming, resource allocation, and commitments to achieve the national objective of Chlorhexidine uptake of 52% after the fifth year of national scaleup.
more
The global pandemic has highlighted fragility in international supply chains and the dependency of many African countries on imported personal protective equipment (PPE). Market pressures have also increased prices for imported supplies and put additional pressure on areas with limited resources for
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procurement. There is an urgent operational need to develop the domestic capacity to supply PPE from within the African continent. There is huge variation in Member
States industrial manufacturing capacity and the regulatory and testing capacity of government agencies at present. Growing number of companies, including micro- and small-medium enterprises, have responded by repurposing, albeit temporarily, to manufacture an assortment of PPEs. This workshop aims to bring together government representatives, industry, and subject matter experts on material testing and standards to promote the development of domestic production of safe and effective PPE made in Africa.
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Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera
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ble challenges to securing long-term polio vaccine security.
This framework is designed to enhance the efforts of existing structures and workstreams within the Global Polio Eradication Initiative (GPEI) and other stakeholders by improving communication and coordination on vaccine security. Ensuring vaccine security is crucial for maintaining a timely, sustained, and uninterrupted supply of affordable, quality-assured polio vaccines in the global fight to achieve and sustain a polio-free world. However, challenges such as fragmented approaches, short-term planning, a dynamic policy environment, and a diverse product pipeline present significant risks to long-term vaccine security. This framework emphasizes the need for alignment and coordination across key polio operational domains, including Poliovirus Containment, Research and Development, and Vaccine Manufacturing and Supply. It also underscores the critical role of normative frameworks and policies in shaping long-term vaccine strategies that guide these operational areas. Additionally, it highlights the importance of cross-cutting elements such as financing and access to resources, along with the integration of communication, coordination, and advocacy efforts, as essential enablers for achieving vaccine security. To secure long-term vaccine supply, it is imperative to enhance alignment and strengthen coordinated efforts across workstreams and with stakeholders, including vaccine manufacturers.
Recognizing that vaccine security is an ongoing endeavor, requiring continuous monitoring and adaptation, this framework will undergo regular updates and revisions. Initially, the management of the framework will be carried out by the GPEI Vaccine Supply Group (VSG).
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First Revised Edition
March 2000
Overview of the WHO Prequalification of Male Circumcision Devices assessment
World Health Organization (WHO); Diagnostics and Laboratory Technology
World Health Organization (WHO); Diagnostics and Laboratory Technology
(2011)
C_WHO
Prequalification of Male Circumcision Devices
PQMC_007 v1 16 December 2011
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
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tion control.
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Laws of Kenya- - PHARMACY AND POISONS ACT
National Council for Law Reporting with the Authority of the Attorney-General
Kenya Law Reports (KLR)
(2012)
C2
CHAPTER 244
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
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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. more
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. more
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