The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op...eraciones y salas de recuperación) y 94 (Estado y seguridad del equipo de radiología e imagenología), que también forman parte del índice de seguridad hospitalaria.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
- Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
- Biorisk Management
- Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
- Biological Waste management
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The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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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 procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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GPHF Minilab manuals on basic dye and thin layer chromatographic testing. The newest version of the manual (Volume I + II) from 2008 is available in three languages: English, French, Spanish. Combining the main manual with the supplements issued each year between 2010 and 2015, label claims on drug... identity and content can now be verified for 75 active ingredients and their fixed-dose combination products using simple, rapid and affordable thin layer chromatographic tests. Please note: Only the demo versions are online available!! The complete manuals are only available after purchasing the Minilab!
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Laboratory Biossafety Manual
Laboratory Biossafety Manual
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
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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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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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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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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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.