High-quality starting materials for medicinal products are essential to the high quality of finished products. In 1995 and 1996 adulterated glycerin caused acute renal failure and subsequently death of about 88 children in Haiti. This case is discussed with respect to risk detection and analysis in the manufacture, distribution, and trade of active as well as nonactive starting materials. Parties involved are not sufficiently aware of the risks. Overall, there is lack of transparency. There is strong need for a Good Trading Practice. Recommendations to health authorities conclude this brief overview.
Council Directive 65/65/EEC of 26 January 1965, on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Official Journal no 22 of 9/2/1965 as last amended by Council Directive 93/39/EEC (Official Journal no L214 of 24/8/1993, p 22).
2.
MunroeG. ICH Q7a. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Draft No.7A, London: Medicines Control Agency; March 17, 2000.
3.
The International Pharmaceutical Excipients Council.Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients. Arlington, VA: International Pharmaceutical Excipients Council; 1997.
4.
WHO Report on Starting materials for pharmaceutical products: Control and Safe Trade. Geneva: World Health Organization, May 25–27, 1998. WHO/Pharm/98.605.
5.
PierceGFalkAJBaxRSiewertM.Starting materials for pharmaceutical products: Safety concerns. WHO Drug In1998;12(3):129–135.
