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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,
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Statutory Instrument 150 of 1991 | S.I. 150 of 1991 | Amended by S.I.’ s 298/93, 61/94, 319/94, 199/98, 256/98, 36/99, 24/2001 and 257/2002, 105 and 222 /2004
A practical toolkot
An Indicator-based Approach - This manual presents an indicator-based approach for rapidly assessing pharmaceutical management systems and programs. The manual contains a set of 46 indicators of performance, grouped under eight topics of pharmaceutical management, with each topic being covered by a
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Manual of Operations
First Edition 2016
4th edition. This is fourth edition of Treatment of tuberculosis: guidelines, adhering fully to the new WHO process for evidence-based guidelines. Several important recommendations are being promoted in this new edition
Accessed November, 2017
Antibiotics and other antimicrobial agents are invaluable life savers, particularly in resource-limited countries where infectious diseases are abundant. Both uncomplicated and severe infections are potentially curable as long as the aetiological agents are susceptible to the
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The conduct of COVID-19 vaccine trials in the context of a candidate vaccine being issued with Emergency Use Designation raises challenging ethical questions, including in relation to the use of placebo controls and unblinding of trial participants in current and future COVID-19 vaccine trials. This
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