Vol. 22, No. 2
Books and Publications
Publication from the World Health Organization
WHO Expert Committee on Specifications for Pharmaceutical
Preparations, 35th Report, Technical Report Series No. 885
1999, vi + 156 pages (available in English; French and Spanish in preparation),
ISBN 92-4-120885-6, CHF 35.-/USD 31.50; In developing countries: CHF
24.50, Order No. 1100885.
This book provides a progress report on a number of WHO activities
intended to support a comprehensive approach to the quality assurance
of pharmaceutical products. Although the report has global relevance,
its guidance is of particular importance in countries attempting to
establish or strengthen a regulatory framework for pharmaceutical products.
All recommendations share the ultimate goal of helping regulatory authorities
safeguard the health of patients by protecting them from substandard
or counterfeit products.
The report has two parts. The first provides a summary of several ongoing
activities coordinated by WHO. These include the continuing development
of the International Pharmacopoeia, the establishment of International
Chemical Reference Substances and International Infrared Reference Spectra,
guidelines for good manufacturing practices, work on the standardization
of nomenclature and terminology, and support to countries seeking to
establish drug regulatory legislative systems.
The second and most extensive part consists of nine annexes. The first
two provide updated lists of available International Chemical Reference
Substances and International Infrared Reference Spectra. The remaining
annexes set out international guidelines and recommendations covering
a range of activities central to the quality control and regulation
of pharmaceutical products. Revised general guidelines for the establishment,
maintenance, and distribution of chemical reference substances are issued
in line with recent refinements in pharmaceutical and analytical methods,
and the continuing need to harmonize the use of comparative standards
for pharmaceutical testing and control.
Two subsequent annexes supplement WHO guidelines for good manufacturing
practices. The first provides advice on the role, functions, and training
of the authorized person, within a manufacturing establishment, responsible
for the release of batches of finished products for sale. The second
describes good practices for the manufacture of pharmaceutical excipients.
Topics covered include self-inspection and quality control, use and
cleaning of equipment, quality control of starting materials, and good
practices in production and quality control. Additional guidelines cover
the inspection of drug distribution channels as a means of ensuring
that quality drugs reach patients, and present a framework, consisting
of core activities, goals, and areas where national standards are needed,
for promoting good pharmacy practices in community and hospital pharmacy
Additional guidelines on national drug regulatory legislation establish
guiding principles for small drug regulatory authorities. General advice
on points to consider when drafting national legislation and defining
the scope of the marketing authorization procedure is followed by a
detailed example of a legislative scheme, including model legislative
text and commentary. Intended to assist drug regulators, those drafting
legislation, and decision-makers, the guidelines should prove of immediate
value to small national drug regulatory authorities with limited human
and other resources. Also included is a provisional legislative scheme
for the registration of pharmacy personnel. The report concludes with
provisional guidelines for developing training programs for the inspection
and examination of counterfeit pharmaceuticals.