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 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...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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This checklist covers five areas of competence needed by health care providers to provide quality of care in contraceptive information and services including: respecting users’ privacy and guaranteeing contfidentiality, choice, accessible and acceptable services, involvement of users in improving ...services and fostering continuity of care and follow-up.
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External quality assessment (EQA) is an important component of quality systems for blood transfusion services. Establishing external quality assessment programmes for screening of donated blood for transfusion-transmissible infections (TTI): implementation guide aims to support WHO member States in ...establishing and operating EQA programmes for screening donated blood for TTI. The guides has been designed for use by national health authorities and EQA organizing institutions in the development of EQA programme. It will also give participating laboratories an insight into the organization of EQA programmes for TTI screening and an understanding of the benefits of participation.
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The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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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...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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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... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Laboratory Biossafety Manual
Laboratory Biossafety Manual