WHO Expert Committee on specifications for pharmaceutical preparations : (Record no. 11717)

MARC details
000 -LEADER
fixed length control field 02442nam a2200205Ia 4500
003 - CONTROL NUMBER IDENTIFIER
control field NULRC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20250520100709.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 250520s9999 xx 000 0 und d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9789241209373
040 ## - CATALOGING SOURCE
Transcribing agency NULRC
050 ## - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS 51 .W67 2006
245 #0 - TITLE STATEMENT
Title WHO Expert Committee on specifications for pharmaceutical preparations :
Remainder of title fortieth report.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Geneva, Switzerland :
Name of publisher, distributor, etc. World Health Organization,
Date of publication, distribution, etc. c2006
300 ## - PHYSICAL DESCRIPTION
Extent iii, 461 pages ;
Dimensions 24 cm.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references.
505 ## - FORMATTED CONTENTS NOTE
Formatted contents note Introduction -- General Policy -- Quality control- specifications and tests -- Quality control- international Reference Materials -- Quality control- national laboratories -- Quality assurance- Good Manufacturing Practices -- Quality assurance- inspection -- Quality assurance- distribution -- Quality assurance- risk analysis -- Quality assurance- stability -- Prequalification -- Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products -- Donations of medicine
520 ## - SUMMARY, ETC.
Summary, etc. This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Annexes include: a list of available international chemical reference substances and international infrared spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element DRUG QUALITY CONTROL
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Library of Congress Classification
Koha item type Books
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Collection Home library Current library Shelving location Date acquired Source of acquisition Total checkouts Full call number Barcode Date last seen Copy number Price effective from Koha item type
    Library of Congress Classification     Pharmacy LRC - Main National University - Manila General Circulation 05/04/2015 Donation   GC RS 51 .W67 2006 NULIB000009476 05/20/2025 c.1 05/20/2025 Books