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.
This document provides a systematic approach in developing a coordinated, standardized, reliable, efficient, cost-effective, and sustainable specimen transport and referral system to support IVHD and VL testing networks. This document provides technical and programmatic recommendations on the approp...riate specimen storage and transportation of specimens for HIV VL and IVHD testing. Along with the national guidelines for specimen storage and transport, these standards should provide guidance on the creation or improvement of specimen referral networks and specimen transport systems. In addition, standard operating procedures (SOPs) targeting drivers and persons responsible for packing of specimens and results return are included in this document.
No publication year indicated in the document.
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Specific Objectives
• To increase the knowledge and awareness of personnel on chemical management.
• To educate the personnel on the potential adverse health effects of chemical exposure.
• To educate the personnel on the existing laws pertaining to handling of hazardous
chemicals.
• To... promote safe and healthy work practices among personnel during chemical handling.
• To guide the personnel on transportation, storage and disposal of hazardous chemicals.
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to ...see: it is estimated that each year, drug-resistant infections result in at least 25 000 patient deaths and cost the EU EUR 1,5 billion in healthcare costs and through loss of productivity
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The Libyan national action plan has been aligned with WHO five objectives. Analysis of the current situation and addressing the gaps and the needs to reach the main goal “one health” approach involves several national sectors and actors, including human and veterinary health, agriculture and foo...d and drug control center and environmental agencies. Therefore, a large committee of all stakeholders was formed with four technical subcommittees were established to addresses every aspect to contain antimicrobial resistance in the country.
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This document provides guidance on how to implement contact screening and chemoprophylaxis with single-dose rifampicin. The contents are logically ordered: counselling and obtaining consent, identification and listing of index case, listing of contacts, tracing of contacts, screening of contacts, ad...ministration of prophylactic drugs. Managerial aspects to undertake contact screeninig and chemoprophylaxis are also elaborated, including planning , training , supervision and drug management.
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Ghana's attempt to regulate health care waste management started in 2002 with the development of guidelines on health care waste manage-ment by the Environmental Protection Agency (EPA). In 2006, the Ghana Health Service (GHS) also developed the Health Care Waste Management Policy and Guidelines as ...a single document.
Although awareness on Health Care Waste Management (HCWM) has improved in recent years, there is the need for a systematic approach to improve on effective segregation, safe collection, and storage, as well as ultimate treatment before disposal.
This guideline seeks to ensure that HCW is managed effectively in compliance with existing International Conventions that Ghana is a signatory to, national laws and regulations, and others to be passed in future.
Recommendations for better management of HCW in the nation's health care facilities have been presented in this document. Also, standard operating procedures (SOPs) have been developed to provide
guidance to various levels of the health facilities.
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This document shall serve as the most comprehensive set of guidelines on the safe management of waste generated from heath care activities in the country. It incorporates the requirements of all Philippine laws and regulations governing HCWM and is designed for the use of individuals, public and pri...vate establishments, and other entities involved in segregation, collection, handling, storage, treatment,and disposal of waste generated from heath care activities.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Issues & Regulations Regarding Pharmaceutical Waste Management
These guidelines are based on the 3rd Edition of the WHO Guidelines (Published 2015) World Health Organization’s Guidelines for the treatment of malaria. Additional literature surveys have been undertaken. Factors that were considered in the choice of therapeutic options included effectiveness, sa...fety, and impact on malaria transmission and on the emergence and spread of antimalarial drug resistance. On-going surveillance is critical given the spread of artemisinin resistance in Southeast Asia, although not yet confirmed anywhere in Africa. The guidelines on the treatment of malaria in South Africa aim to facilitate effective, appropriate and timeous treatment of malaria, thereby reducing the burden of this disease in our communities. This is essential to further reduce the malaria case fatality rates currently recorded in South Africa, to decrease malaria transmission and to limit resistance to antimalarial drugs.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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