Chemistry International
Vol. 22, No. 6, November 2000

2000, Vol. 22
No. 6 (November)
..News from ICSU
..News and Notices
..New Projects
..Awards and Prizes
..New Books
..Provisional Recommendations
..Reports from Commissions
..In Memorium
..Conference Announcements
..Conference Calendar

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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@; 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.



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