World Health Organization : Technical Report Series, No. 645: World Health Organization Technical Report Series, No. 645 ; World Health Organization Expert Committee on Specifications for Pharmaceuticals Preparations

By D. Banes, Dr.

Book Id: WPLBN0000168290
Format Type: PDF eBook:
File Size: 2.26 MB
Reproduction Date: 2005

Title:	World Health Organization : Technical Report Series, No. 645: World Health Organization Technical Report Series, No. 645 ; World Health Organization Expert Committee on Specifications for Pharmaceuticals Preparations
Author:	D. Banes, Dr.
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Banes, Dr, B. D. (n.d.). World Health Organization : Technical Report Series, No. 645. Retrieved from http://gutenberg.cc/

Description
Medical Reference Publication

Excerpt
In its twenty-sixth report (3), the WHO Expert Committee on Specifications for Pharmaceutical Preparations considered various aspects of quality assurance in pharmaceutical supply systems and suggested that to fulfil some of the objectives enumerated in resolution WHA28.66 of the Twenty-eighth World Health Assembly relating to the regulatory control of drugs, a comprehensive review of approaches to quality assurance should be recommended. A document containing such a review was considered at the present meeting; it incorporated comments by members of the Expert Panel on the International Pharmacopoeia and Pharmaceutical Preparations and by persons from other interested institutions. A question of definition concerning the terms drug, medicine, 3 - a ~ma terial, pharmaceutical product, etc., arose early in the discussion. While there was agreement that it would not be useful in the present report to depart from the usage reflected in documents

Table of Contents
CONTENTS Page 1 . Quality assurance in pharmaceutical suppl!- systems . . . . . . . . . . . . . . . . . . . . . . . 5 2 . Revision of the International Pharmacopoeia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2.2 Methods of drug analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 2.3 Monographs for pharmaceutical raw materials . . . . . . . . . . . . . . . . . . . . . . . . 8 2.4 Monographs for dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2.5 Monographs for pharmaceutical aids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 3 . International chemical reference substances for pharmaceuticals . . . . . . . . . . . . 13 3.1 Reports from the WHO Collaborating Centre . . . . . . . . . . . . . . . . . . . . . . . . 13 3.2 Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 3.3 Secondary reference substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3.4 International cooperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3.5 Revision of guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 4 . Quality requirements for oral dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 4.1 Tests for solid oral dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 4.2 Tests for liquid oral dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4.3 Guidelines for in-process control of the manufacture of some types of dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 5 . Basic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 5.1 Basic tests for pharmaceutical substances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 5.2 Simple tests for the absence of gross degradation . . . . . . . . . . . . . . . . . . . . . . 21 5.3 Basic tests for tablets and capsules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 5.4 Publication of basic tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Annex 1. Quality assurance in pharmaceutical supply systems . . . . . . . . . . . . . . . . . 25 Annex 2 . Tests for solid oral dosage forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38