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.
Myanmar’s transition to a market‐based economy is accompanied by rapid development of the private manufacturing sector, which has large potential for improving economic growth. The overall success of the sector, however, should not be taken for granted. Future advances will greatly depend on th...e policy and business environment in which manufacturing activities take place. It is, therefore, important to better understand the business environment and help inform policies conducive to sustainable economic growth.
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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 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.
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Doc. No.: INS/GDL/001-(Annexes)
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 these 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
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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... 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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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.
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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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Call to action by the Global Leaders Group on Antimicrobial Resistance on reducing antimicrobial discharges from food systems, manufacturing facilities and human health systems into the environment.
The African Centers for Disease Control and Prevention and the African Union together have called for a New Public Health Order which will safeguard the health and economic security of the continent as it strives to meet the aspirations of the Agenda 2063. A key pillar of this mandate seeks to expan...d the local manufacture of vaccines, diagnostics, and therapeutics. Presently, less than one percent of vaccines administered on the continent are manufactured locally. This places a great burden on the health systems of African countries and reduces their ability to respond to pandemics and other health crises.
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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A view of global supply chains, pressure points, and implications for antimicrobial resistance response
Minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotic.
The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure t...hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
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Despite high regional demand for vaccines valued at over US$ 1 billion annually, Africa’s vaccine industry provides only 0.1% of global supply. Vaccine inequity and hoarding at the start of the pandemic, which resulted in delays in obtaining COVID-19 doses, stimulated new resolve to address future... supply security. In 2021, the AU set a target to produce and supply more than 60% of the vaccine doses on the continent by 2040.
In the last 18 months alone, more than 30 new African manufacturing projects have been announced and estimates indicate that the African vaccine market across all existing and projected novel products could range between US$ 2.8 billion and US$ 5.6 billion by 2040*, demonstrating the potential for a thriving regional industry to emerge.
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