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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
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.
GPHF-Minilab: Manuals
recommended
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...
Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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...
Revision Bulletin ESPNF
Laboratory Biossafety Manual
Laboratory Biossafety Manual
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...
The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...
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...
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...
