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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.
Doc. No.: INS/GDL/001-(Annexes)
Drug Advisory Board
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 these tools to assess coronavirus disease 2019 (COVID...
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...
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...
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,...
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...
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)...
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...
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...
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 advan...
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 antibiotics in water bodies downstream of manufacturing site...
