Informe 40

WHO Technical Report Series
937

ISBN 92-4-120937-2

WHO EXPERT COMMITTEE
ON SPECIFICATIONS FOR
PHARMACEUTICAL PREPARATIONS

Fortieth Report

WHO Technical Report Series — 937

The report is complemented by a number of annexes. These
include: a list of available International Chemical Reference
Substances and International Infrared Spectra; supplementary
guidelines on goodmanufacturing 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 forprocurement 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 ofEssential Medicines immediate-release, solid oral
dosage forms; and additional guidance for organizations
performing in vivo bioequivalence studies.

SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS

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 andspecifications for drug substances
and dosage forms.

Geneva

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8.5.2006 12:10:14

The World Health Organization was established in 1948 as a specialized
agency of the United Nations serving as the directing and coordinating authority
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of human health, a responsibility that it fulfils in part through its extensive
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The Organization seeks through its publications to support national health
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development, WHO publishespractical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and
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To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its
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The WHO Technical Report Series makes available the findings of various
international groups of experts that provide WHO with the latest scientific and
technical advice on a broad range of medical and public health subjects.
Members of such expert groups serve without remuneration in their...