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Annex 5, WHO Technical Report Series 1010, 2018
Revision Bulletin ESPNF
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... 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... more
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... more
Communication to Healthcare Professionals Mar-2020 This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o... more
Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S)... more
In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement... more
This guidance should be followed if an unlicensed medicine is prepared in a registered pharmacy. The preparation of an unlicensed medicine (for example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’. The guidance should be read alon... more
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ... more
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
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... 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,... more
J Pharm Pharm Sci (www.cspsCanada.org) 16(3) 441 - 455, 2013
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 pharmac... more
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 o... 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... more
Drug Distribution and Control: Preparation and Handling–Guidelines Review 2008

A model quality assurance system for procurement agencies

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