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Сборник индикаторов для мониторинга и оценки национальных программ борьбы с туберкулезом
recommended
Борьба с туберкулезом представляет собой одну из ведущих областей, в которых ведется регулярный сбор информации, которая измеряет самые критические показатели вы...
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.
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...
WHO Technical Report Series, No. 908, 2003, Annex 9. This guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It describes the special measures considered appropriate for the storage and transportation of pharmaceuticals.
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...
This Technical Brief reviews current practice and evidence on nutrition-specific preventive approaches to MAM, providing practical guidance for implementers and programme managers, and highlighting gaps in evidence and guidance.
The current guidelines on Integrated Management of Acute Malnutrition (IMAM), addresses the issue of improved management of severe acute malnutrition (SAM), particularly in children under 5 years of age. In the absence of standard protocols, mortality in children admitted to hospital with SAM can ra...
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
...
Drug Advisory Board
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 ...
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...
