World Health Organization Publication : Year 1999 ; Issue 9241545267: Quality Assurance of Pharmaceuticals

By World Health Organization

Description
Medical Reference Publication

Excerpt
Introduction The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution which cites as one of the Organization's functions that it should develop, establish and promote international standards niith respect to food, biological, pharmaceutical and s i d a r products. Every government allocates a substantial proportion of its total health budget to drugs. This proportion tends to be greatest in developing countries, where it may exceed 40%. Without assurance that these drugs are relevant to priority health needs and that they meet acceptable standards of quality, safety and efficacy, any health service is evidently compromised. In developing countries considerable administrative and technical effort is directed to ensuring that patients receive effective drugs of good quality. It is crucial to the objective of health for all that a reliable system of drug control be brought within the reach of every country.

Table of Contents
Contents Introduction 1 1. WHO good manufacturing practices: main principles for pharmaceutical products 6 Introductory note, general considerations and glossary 6 Quality management in the drug industry: philosophy and essential elements 13 Good practices in production and quality control 46 Validation of manufacturing processes 53 Authorized person-role, functions and training 70 2. WHO good manufacturing practices: starting materials 75 Active pharmaceutical ingredients (bulk drug substances) 75 Pharmaceutical excipients 83 3. WHO good manufacturing practices: specific pharmaceutical products 103 Sterile pharmaceutical products 103 Biological products 117 Investigational pharmaceutical products for clinical trials in humans 128 Herbal medicinal products 139 4. lnspection 145 lnspection of pharmaceutical manufacturers 145 lnspection of drug distribution channels 157

Book Id: WPLBN0000165667
Format Type: PDF eBook
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Reproduction Date: 2005
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Title:

World Health Organization Publication : Year 1999 ; Issue 9241545267: Quality Assurance of Pharmaceuticals

Author:

World Health Organization

Volume:

Language:

English

Subject:

Health., Public health, Wellness programs

Collection:

World Health Collection

Subcollection:

Historic
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World Health Organization

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