Information and Approaches for developing Country Settings
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.
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.
more
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.
more
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.
more
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
more
En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op...eraciones y salas de recuperación) y 94 (Estado y seguridad del equipo de radiología e imagenología), que también forman parte del índice de seguridad hospitalaria.
more
A Community Guide to Environmental Health > Chapter 19: Health Care Waste. Please download this chapter from the website of Hesperian
The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
more
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
more
Countries who have no testing capacity and national COVID-19 laboratories with limited experience on COVID-19 virus testing are encouraged to send the first five positives and the first ten negative COVID-19 samples to WHO reference laboratories providing confirmatory testing for COVID-19.
Updates ...29 April 2020
more
Настоящие «Основные индикаторы и цели ВОЗ по усилению лабораторных служб в рамках стратегии по ликвидации туберкулёза» по ликвидации туберкулеза служат руководс...твом для всех стран, разрабатывающих планы по укреплению лабораторного потенциала на 2016–2025 гг
more
A GTFCC course on sample collection and testing with rapid diagnostic tests (or RDTs) for cholera, for healthcare workers.