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.
Treatment Recommendations for Adult Inpatients
SOP- Quality Assurance of Malaria Diagnostic Tests
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its objectives are to minimize... the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance.
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Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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This book provides significantly expanded content and experience in relation to a broader stewardship context- for example, stewardship in specific populations, different countries as well as the role of different professions in stewardship to political and media engagement. We hope this book has so...mething to offer everyone practicing in this area. Therefore, The British Society for Antimicrobial Chemotherapy [BSAC] in collaboration with ESGAP are very pleased to present this e-book on Global Antimicrobial Stewardship that is relevant to health care professions working in preventing and managing infection across the healthcare communities and health care facilities. It aims to support health care professionals, or teams, or policy makers interested in learning about bringing the principles of stewardship to the bed side
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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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,... 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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This document provides interim guidance to countries on testing considerations and strategies for suspect cases of severe acute hepatitis of unknown aetiology in children. It is primarily intended for clinical, programmatic, laboratory and diagnostic stakeholders across Member States and national pu...blic health authorities involved in the identification and investigation of cases of severe acute hepatitis in children.
This document is part of a package of guidance for this event, which includes suggested minimum reporting variables and a clinical Case Report Form support Member States with case investigation and reporting.
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