Essential medicines and health products

Control and safe trade of starting materials for pharmaceutical products

WHO/PHARM/98.605
21 March 2005

Introduction

The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. This includes the quality of starting materials, including active substances and excipients, for the production of medicinal products. For the purposes of this report, packaging materials are also covered. Any risks that may emanate from starting materials of inappropriate quality must be avoided for the benefit and safety of patients using medicinal products. In 1995 and 1996 more than 80 children died in Haïti following ingestion of a cough-and-cold syrup containing glycerol contaminated with diethylene glycol. During the last 60 years worldwide more than 500 patients have died due to such intoxications. This fact has induced WHO to convene a consultation on the production of starting materials of good quality, the maintenance of that quality throughout the distribution chain, and the confirmation of the quality by the users of starting materials. The objective was to formulate recommendations for the parties concerned.

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