Issue Date: May 12, 2008
I know it is easy to jump on the bandwagon and point a finger at outside suppliers when the issue of a contaminated drug arises (C&EN, March 31, page 8). However, I was amazed that none of the reports mentioned that, ultimately, the companies that put their names on the final product label, Baxter Healthcare and B. Braun Medical in the case of contaminated heparin, should take responsibility for ensuring that their supplier meets predetermined specifications before accepting any lots of active pharmaceutical ingredients (API). If they had accepted the material and proceeded with drug product production, they must have agreed that the API was of acceptable quality.
A discussion on what acceptance criteria were set in the specifications and how the contaminant escaped the companies’ quality-control/quality-assurance system may help readers understand the real issue and prevent other companies from repeating such mistakes.
Thousand Oaks, Calif.
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