The Art of Raw Materials and Supplier Qualification

by Paula J. Shadle, PhD
Volume 3, Issue 6 (November/December 2004)

Regulations and common sense require that a manufacturer qualify both the raw materials and the suppliers the firm will use to produce GMP supplies of a pharmaceutical or biopharmaceutical. Because the firm is accepting legal liability for the quality of all raw materials, it makes good business sense to devote resources to these activities. This article explores how to assure that qualification is complete, efficient, and compliant with current good manufacturing practice (cGMP), and discusses the challenges faced by today’s manufacturers…

Shadle PJ. The Art of Raw Materials and Supplier Qualification. BioProcess J, 2004; 3(6): 43-46.