Capability and Performance
Unofficial Translation
Approved by the Federal Government on October 20, 2016
WHO/HTM/HIV/2007.01 WHO/HTM/TB/2007.380
Accessed 3rd of October 2015
This document defines the framework for Malawi’s National HIV Programs. Considering public health benefits and risks, as well as funding and resource implications, deviations from these guidelines are not supported by the Ministry of Health.
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
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Paper commissioned for the EFA Global Monitoring Report 2010, Reaching the marginalized