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 Ministry of Health of Saudi Arabia has developed the guidelines to meet the urgent need for up -to-date information and evidence-based recommendations
Test de connaissances après formation
Information and Approaches for developing Country Settings
Глобальными приоритетами для лечения туберкулеза (ТБ) и борьбы с ним являются улучшенное и ранее выявление случаев туберкулеза, в том числе случаев заболевания с о...трицательным мазком мокроты, которые часто ассоциируются с вирусом иммунодефицита человека (ВИЧ) и ранним возрастом, а также расширенные возможности для диагностики туберкулеза с множественной лекарственной устойчивостью (МЛУ-ТБ)
more
The new, all oral, 20-month MDR-TB regimens range from US $1,600* (using bedaquiline and linezolid for 6 months and levofloxacin as the fluoroquinolone) to US $2,100* (using linezolid for 12 months and moxifloxacin as the fluoroquinolone.
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
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
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
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
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 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