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.
Quality Assurance (QA) and Quality Improvement (QI). The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement clinical facility and service assessments. At the website you will find checklists intended to be used with the clinical fa...cility assessment guide
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This field guide is designed for use by FHI 360 staff and partner organizations responsible for ensuring quality clinical services, at both facility and non-facility levels. The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement cl...inical facility and service assessments.
The accompanying checklists are intended to be used with the clinical facility assessment guide.
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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...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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This guide is an introduction on how to integrate logistics management information systems (LMIS) with geographic information systems (GIS). It covers the value of integrating these two systems, the steps in assessing if it is currently viable to link the systems, how to set the linkage, the process...es for using LMIS within a GIS platform, and finally how to sustain the linkage. The aim of this guide is to assist logistics managers, decisionmakers and technical experts in understanding the value of integrating GIS and of the process involved in integrating these two systems.
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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An Adaptation of COPE
(Client-Oriented, Provider-Efficient Services)
For the toolbox visit: http://www.engenderhealth.org/pubs/maternal/obstetric-delivery-care.php
This manual has been designed to be used in conjunction with two earlier WHO publications, "Basic tests for pharmaceutical substances" (1986) and "Basic tests for pharmaceutical dosage forms" (1991). Most of the pharmaceutical substances and dosage forms covered are included in the WHO Model List of... Essential Drugs. The present volume describes procedures for testing a further 23 pharmaceutical substances and 58 pharmaceutical dosage forms and also for testing 4 medicinal plant materials.
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Operational guidance for managing programme quality.
These guidelines are about implementing the programme-quality standards of the Core Humanitarian Standard in limited access humanitarian response. They have been developed using approaches and tools tested by Oxfam, other INGOs and the UN in Afgh...anistan, DRC, Iraq, Somalia, Syria and Yemen. The guidelines are an operational resource to help programme designers and decision makers deliver ‘good enough’ programme quality in limited access humanitarian response.
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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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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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Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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The key actions, activities, and approaches in this document are organized within each of the 5Cs (see Table 1 in the PDF) and those of the Strategic preparedness and response plan (SPRP) pillars as follows:
National action plan key activities, prioritized for the current context and the current ...understanding of the threat of SARS-CoV-2
A. Transition from emergency response to longer term COVID-19 disease management.
B. Integrate activities into routine systems.
C. Strengthen global health security.
Special considerations for fragile, conflict-affected and vulnerable (including humanitarian) settings
WHO global and regional support to Member States to implement their national action plans
Key guidance documents for reference
This is a living document that will be updated to incorporate new technical guidance in response to the evolving epidemiological situation. National plans should be implemented in accordance with the principles of inclusiveness, respect for human rights, and equity.
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WHO’s Country Cooperation Strategy (CCS) defines the Organization’s medium-term vision for working in and with a particular country. The CCS, developed in the context of global and national health priorities, examines the overall health situation in a country, including the state of the health s...ector, socioeconomic status and the major health determinants.
This CCS sets out WHO’s strategic framework for collaboration with the Syrian Arab Republic, from June 2022 until June 2025, in light of the 12 years of crisis that have had a devastating impact on the health sector and infrastructure of basic services. It carefully considers the current and projected issues during its transition from continued humanitarian assistance to recovery, resilience and development. The consolidation of health policies and strategies and health system strengthening, based on the strengthening of primary health care (PHC), aims to contribute to the achievement of national and global development and health goals and the targets of the SDGs.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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