This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
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.
Quality Assurance (QA) and Quality Improvement (QI). The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement clinical facility and service assessments. At the website you will find checklists intended to be used with the clinical fa...cility assessment guide
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This field guide is designed for use by FHI 360 staff and partner organizations responsible for ensuring quality clinical services, at both facility and non-facility levels. The guide provides general information on how to organize, implement and follow up on quality assurance/quality improvement cl...inical facility and service assessments.
The accompanying checklists are intended to be used with the clinical facility assessment guide.
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This checklist covers five areas of competence needed by health care providers to provide quality of care in contraceptive information and services including: respecting users’ privacy and guaranteeing contfidentiality, choice, accessible and acceptable services, involvement of users in improving ...services and fostering continuity of care and follow-up.
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An Adaptation of COPE
(Client-Oriented, Provider-Efficient Services)
For the toolbox visit: http://www.engenderhealth.org/pubs/maternal/obstetric-delivery-care.php
This manual has been designed to be used in conjunction with two earlier WHO publications, "Basic tests for pharmaceutical substances" (1986) and "Basic tests for pharmaceutical dosage forms" (1991). Most of the pharmaceutical substances and dosage forms covered are included in the WHO Model List of... Essential Drugs. The present volume describes procedures for testing a further 23 pharmaceutical substances and 58 pharmaceutical dosage forms and also for testing 4 medicinal plant materials.
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This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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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... 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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The objective of this course is to provide high-level information and contextual understanding of WHO Standard Operating Procedures (SOPs) for Emergencies.
We will explore a range of topics, ranging from the Emergency Response Framework (ERF), to planning, grants and finance, procurement, risk mana...gement, rosters and deployment, and ethics.
Each module within this course is standalone. Therefore, you can take the modules in any order – with the exception of the Course Review. The Course Review is a question-based revision module that recaps the content covered in modules 1 to 10.
The target audience for this course is personnel who will be assigned by WHO to go on deployment in response to health emergencies.
The course is available in English and French
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Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug 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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Laboratory Biossafety Manual
Laboratory Biossafety Manual
The key actions, activities, and approaches in this document are organized within each of the 5Cs (see Table 1 in the PDF) and those of the Strategic preparedness and response plan (SPRP) pillars as follows:
National action plan key activities, prioritized for the current context and the current ...understanding of the threat of SARS-CoV-2
A. Transition from emergency response to longer term COVID-19 disease management.
B. Integrate activities into routine systems.
C. Strengthen global health security.
Special considerations for fragile, conflict-affected and vulnerable (including humanitarian) settings
WHO global and regional support to Member States to implement their national action plans
Key guidance documents for reference
This is a living document that will be updated to incorporate new technical guidance in response to the evolving epidemiological situation. National plans should be implemented in accordance with the principles of inclusiveness, respect for human rights, and equity.
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The aim of this guidance manual is to introduce the user to project/programme plan- ning in a Red Cross Red Crescent environment. It describes the different stages of the planning phase of the “project/programme cycle” within the context of Results-Based Management (RBM). It also gives an overvi...ew of the various components of RBM and explains how to integrate and apply this approach in practice. In addition, the manual summarizes briefly the other key phases of the cycle (assessment, imple- mentation and monitoring, evaluation) and provides references to the key Federation manuals on these phases.
The manual has been developed primarily for use by people managing projects and programmes either in a National Society or the secretariat of the International Federation of Red Cross and Red Crescent Societies (International Federation). Although it is mainly designed for use at the country level, the basic principles can be applied to project and programme planning at any level. The manual draws on two International Red Cross and Red Crescent Movement publications – the International Federation’s Project Planning Process (2002) and the ICRC Economic Security Unit’s Programme/ Project Management: The Results-Based Approach (2008) – reflecting the significant similarity of approach. The International Federation has developed the manual internally to suit the particular needs and uses of project/programme management within the organization.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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