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
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Close this folderNational laboratories for drug quality surveillance and control1
View the document1. Introduction
View the document2. First-stage laboratory for drug surveillance
Open this folder and view contents3. Medium-size drug control laboratory
View the document4. Scope of activity
View the document5. Factors influencing the size and location of a laboratory
Close this folder6. Implementation of control laboratory projects
View the document6.1 Feasibility study
View the document6.2 Phasing of development
View the document6.3 Programme support
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
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
6.1 Feasibility study

Before any definitive steps are taken to establish a national laboratory service for drug control, a feasibility study must be put in hand to assess, within the context of prevailing needs and legal and administrative provisions, the precise functions it will serve, the scale of operation, and the projected costs. Provision must be made in the costing for: land and/or buildings, services, furnishings, equipment, consultancy fees, training of staff, and routine maintenance and operational costs. The necessity or practicability of phasing the development of the service should also be examined.

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