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Procedure for the development of World Health Organization medicines quality assurance guidelines
1. Introduction:
The process described in this annex is designed to ensure wide consultation and transparency when developing the World Health Organization (WHO) norms and standards for medicines quality assurance for WHO’s Member States. These quality assurance (QA) guidelines include good practice quality guidelines and regulations (GXPs) and technical regulatory guidance. The steps outlined in Section 3 are designed to ensure that these texts are made available in a timely manner. These QA guidelines are developed and maintained up to date under the aegis of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), in line with WHO rules and procedures governing expert committees, adopted by WHO Member States. The steps involved in the development of specifications and monographs for inclusion in The International Pharmacopoeia (1) are addressed separately (2–4).
QA guidelines are the recognized WHO technical standards to support the whole life-cycle of medical products, from development through to production (for example, good manufacturing practices, quality control, inspectorate guidelines), marketing authorization (for example, stability and bioequivalence) and distribution (good distribution practices), up to the post-marketing phase (for example, WHO Guidelines on the conduct of surveys of the quality of medicines (5) and WHO guidance on testing of “suspect” falsified medicines (6)).
To reflect the constant technical progress in pharmaceutical development, production, regulatory science and quality control, it is crucial that QA guidelines and guidance texts are kept up to date, that they reflect science, and that the WHO procedures to elaborate or review them are flexible enough to allow rapid interventions by regulators, while maintaining a rigorous public consultation process with all stakeholders.
QA guidelines provide an important element of the quality dimension for the medical products (included on the basis of their efficacy and safety) in the WHO Model List of Essential Medicines (7) and in WHO treatment guidelines. Major WHO programmes, such as the Prequalification Team-Medicines, and others managed by partner organizations, such as the United Nations Children’s Fund and The Global Fund to Fight AIDS, Tuberculosis and Malaria, rely heavily upon the quality specifications set out in The International Pharmacopoeia (1) and in the QA guidelines.
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WHO TRS (Technical Report Series) 1019, 2019 Annex 1:
