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WHO manual for organizing a national external quality assessment programme for health laboratories and other testing sites

World Health Organization WHO, (2016)


This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
http://apps.who.int/iris/bitstream/10665/250117/1/...


GPHF-Minilab: Manuals

Global Pharma Health Fund E.V., (2008)


GPHF Minilab manuals on basic dye and thin layer chromatographic testing. The newest version of the manual (Volume I + II) from 2008 is available in three languages: English, French, Spanish. Combining the main manual with the supplements issued each year between 2010 and 2015, label claims on drug identity and content can now be verified for 75 active ingredients and their fixed-dose combination products using simple, rapid and affordable thin layer chromatographic tests. Please note: Only the demo versions are online available!! The complete manuals are only available after purchasing the Minilab!
http://www.gphf.org/en/minilab/manuals.htm


Regional Strategy on Regulation of Medical Products in the African Region, 2016–2025

World Health Organization, Regional Office for Africa , (2016)


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 professionals, 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.
http://reliefweb.int/sites/reliefweb.int/files/res...


WHO Guidelines on Good Manufacturing Practices (GMP) for Herbal Medicine

World Health Organization WHO, (2007)


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.
http://apps.who.int/medicinedocs/documents/s14215e...


Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa

World Health Organization WHO, (2011)


The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls over antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
http://www.who.int/medicines/publications/WHO_QAMS...


SAFETY MONITORING of MEDICINAL PRODUCTS

Uppsala Monitoring Centre, Eds.: World Health Organization, (2012)


Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmacovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
http://www.who.int/medicines/areas/quality_safety/...


MSF Qualification Scheme for International Pharmaceutical Supply

Medicins Sans Frontieres, (2009)


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. purchase 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.
http://www.msf.org/sites/msf.org/files/old-cms/fms...


Basic Tests for Drugs - Pharmaceutical substances, medicinal plant materials and dosage forms

World Health Organization, (1998)


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.
http://whqlibdoc.who.int/publications/1998/9241545...


a model quality assurance system for procurement agencies

World Health Organization, Eds.: World Health Organization, United Nations Children's Fund, United Nations Development Programme, United Nations Populations Fund, World Bank, (2007)


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 distribution of pharmaceutical products.
http://apps.who.int/medicinedocs/documents/s14866e...


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