This field study to assess the pharmaceutical situation was undertaken in Ghana in May-June 2008 using a standardized methodology developed by the World Health Organization. The study assessed medicines availability and affordability, geographical accessibility, quality and r...ational use among other issues. The survey was conducted in six regions. In each region, 6 public health care facilities, 12 private pharmacies and 1 warehouse were surveyed.
more
Extract from "Essentials of Pharmaceutical Practice - EPP Handbook" by Ecumenical Pharmaceutical Network (EPN) (ISBN 978-9966-094-44-5). Chapter contents: Definition and understanding about SOPs - Importance of SOPs - Role of SOPs in ensuring quality of services in the pharmacy - Developing SOPs fo...r various processes carried out in the pharmacy - Making effective and active use of SOPs.
more
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
Psychatry & Pediatrics
Chapter I.3
Master of Science in Pharmaceutical Management Dissertation
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
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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
European Journal of Biomedical and Pharmaceutical Sciences, vol.3 (2016) 1, 192-206
This review shows that if all sub areas of pharmaceutical waste management can efficiently work back to back environmental pollution and dangers to human health can reduce significantly.
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
PNAS 119 (8) e2113947119 | https://doi.org/10.1073/pnas.2113947119
Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, m...easure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Furthermore, comparison of the existing data, generated for different studies/regions/continents, is challenging due to the vast differences between the analytical methodologies employed. Here, we present a global-scale study of API pollution in 258 of the world’s rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. Samples were obtained from 1,052 locations in 104 countries (representing all continents and 36 countries not previously studied for API contamination) and analyzed for 61 APIs. Highest cumulative API concentrations were observed in sub-Saharan Africa, south Asia, and South America. The most contaminated sites were in low- to middle-income countries and were associated with areas with poor wastewater and waste management infrastructure and pharmaceutical manufacturing. The most frequently detected APIs were carbamazepine, metformin, and caffeine (a compound also arising from lifestyle use), which were detected at over half of the sites monitored. Concentrations of at least one API at 25.7% of the sampling sites were greater than concentrations considered safe for aquatic organisms, or which are of concern in terms of selection for antimicrobial resistance. Therefore, pharmaceutical pollution poses a global threat to environmental and human health, as well as to delivery of the United Nations Sustainable Development Goals.
more
2014-2020, Draft March 2014