Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Close this folder3. Distribution
Close this folderQuality assurance in pharmaceutical supply systems1
View the document1. Introduction and general considerations
Close this folder2. Elements of quality assessment and assurance
View the document2.1 Legal base
View the document2.2 Regulatory elements
View the document2.3 Technical elements
Open this folder and view contents3. Pre-marketing quality assessment
Open this folder and view contents4. Drug quality surveillance during marketing
View the documentReferences
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 
2.1 Legal base

Drug quality assessment and assurance should have an adequate legal framework forming an integral part of general drug legislation. All regulatory and technical elements of quality assessment and assurance require the provision of legal powers to undertake these activities and to prescribe norms. The enabling legislation should provide the necessary authority to develop particular regulations in connexion with quality assurance during the manufacture, importation and distribution of pharmaceutical products and, in some cases, pharmaceutical raw materials. Additional regulations governing the practice of pharmacy, which form part of health legislation, may also be relevant here.

The responsibility for the development of guides, norms, and administrative regulations may frequently be assigned to a drug control agency. Wide differences in legal approaches exist between countries according to whether the administrative structure is centralized or decentralized. It is, however, possible in the case of a decentralized system to establish legislation that permits the sharing of responsibility, and the coordination of all activities in the quality assessment of pharmaceutical supply systems.

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