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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.
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)...
In October 2022, President Biden signed the Global Malnutrition Prevention and Treatment Act (GMPTA) into law, which directs USAID to prevent and treat malnutrition globally. The GMPTA further codifies USAID’s leadership on nutrition, with a focus on evidence-based interventions across health syst...
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...
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,...
Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
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 ...
Impact of EU policies on accessing protection. The report highlights the tragedy hundreds of thousands of people face when seeking protection in Europe. Women, men and children escaping war, repression and violation of human rights often turn to Europe in the hope of finding a safe haven. But many a...
Drug Advisory Board
Biosafety involves the implementation of containment principles, technologies and practices to prevent unintentional exposure to biological agents. Biosecurity involves the protection, control and accountability of biological materials and information related to these materials and dualuse research,...
2 April 2022
Основные аспекты обеспечения биологической безопасности в лабораторных условиях в связи с распространением вируса SARS-CoV
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...
“Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. Some of the vector control interventions deployed in complex emergencies and in response to natural disasters – namely insecticide-treated nets (ITNs) and indoo...
Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPC published here describes the characteristics of new types of insecticide-treated nets (ITNs) to control malaria transmission in areas with insecticide-resist...
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
...
Guidance for the preparation and submission of dossiers
