Chemistry International
Vol. 22, No. 6
November 2000
New
Publication from the World Health Organization
Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and
Related Materials, Volume 2: Good Manufacturing Practices and Inspection
1999, v + 196 pages (available in English; French in preparation),
ISBN 92-4-154526-7, CHF 62.-/USD 55.80; In developing countries: CHF 43.40,
Order No. 1152452. WHO Marketing and Dissemination, CH-1211 Geneva 27,
Switzerland; E-mail: bookorders@ who.ch;
Tel.: +41 22 791 24 76; Fax: +41 22 791 48 57.
This book draws together 12 WHO guidelines related to good manufacturing
practices (GMP) and to the inspection of pharmaceutical manufacturers
and drug distribution channels. Most of these guidelines have appeared
as annexes in various reports of the WHO Expert Committee on Specifications
for Pharmaceutical Preparations. By making these guidelines available
in a single reference work, the book facilitates access to the complete
body of WHO guidelines and recommendations aimed at ensuring that pharmaceutical
products are manufactured in compliance with internationally accepted
standards for quality and safety.
Guidelines are presented in four chapters. Chapter 1 reproduces the
core GMP guidelines, which set out the philosophy and essential elements
of GMP and define good practices in production and quality control.
Guidelines for the validation of manufacturing processes explain and
promote the concept of validation embedded in the core GMP texts. The
guidelines can also be used to establish priorities and select approaches
when a validation program is being developed. Chapter 1 concludes with
an explanatory text describing the role, functions, and training of
the person authorized to release batches of finished products for sale.
The two guidelines in the next chapter, on starting materials, provide
GMP for active pharmaceutical ingredients and for the manufacture of
pharmaceutical excipients. As strict application of full GMP is not
always practical or necessary for starting materials, these guidelines
outline the procedures and practices that manufacturers should employ
to ensure that the methods, facilities, and controls used for their
production are operated or managed so that phamaceutical starting materials
have the quality and purity appropriate for use in finished pharmaceutical
products.
Chapter 3 reproduces four sets of specialized guidelines for specific
pharmaceutical products. Guidelines for sterile pharmaceutical products
cover the additional steps necessary to minimize the risks of microbiological,
particulate, and pyrogen contamination in sterile products. The second
guidelines set out GMP for the special case of products manufactured
with biological materials and processes. GMP for investigational products
specifically address those manufacturing practices that may be different,
given the fact that investigational products for clinical trials in
humans are not usually manufactured in accordance with a set routine,
and may be incompletely characterized during the initial stages of clinical
development. Chapter 3 concludes with GMP for the manufacture of herbal
medicinal products, giving particular attention to procedures and techniques
that are substantially different from those employed in the manufacture
and quality control of conventional products.
The final chapter includes provisional guidelines for the inspection
of pharmaceutical manufacturing facilities, aimed at enforcing GMP compliance,
and guidelines for the inspection of drug distribution channels, aimed
at ensuring that drug quality is maintained throughout the pharmaceutical
supply system or distribution network.