Doc. No.: INS/GDL/001-(Annexes)
Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug
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products for individual patients. Included in this document is information on facilities and equipment, ingredient selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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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
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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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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 guide
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lines 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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Rwanda Guidelines for variation to registered pharmaceutical products.
The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used i
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n the context of COVID-19. This includes WHO Priority Medical Devices, specifically: surgical masks, non-surgical masks, gloves, googles, face shields, gowns and N95 masks. It is intended for procurement agencies, occupational health departments, infection prevention and control departments or focal points, health facility administrators, biomedical and materials engineering, PPE manufacturers and public health authorities at both national and facility levels.
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Confronted with the important issue of patient safety, in 2002 the Fifty-fifth World Health Assembly adopted a resolution urging countries to pay the closest possible attention to the problem and to strengthen safety and monitoring systems. In May 2004, the Fifty-seventh World Health Assembly approv
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ed the creation of an international alliance as a global initiative to improve patient safety. The World Alliance for Patient Safety was launched in October 2004 and currently has its place in the WHO Patient Safety programme included in the Information, Evidence and Research Cluster.
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This manual is about the basic nursing care - desinfection, cleaning, sterilization, nursing documentation, hygiene, surgical care and preparation and much more. This booklet has been prepared by the NED Volunteers Foundation.
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
The WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood to laboratories/blood banks.
23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc
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tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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Three Years After Enactment of the Drug Quality and Security Act
The new WHO guidelines provide recommended steps for safe phlebotomy and reiterate accepted principles for drawing, collecting blood and transporting blood to laboratories/blood banks.