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Animal Tales
Author: Michael H. Anisfeld
Note: This article was originally published in the Autumn 2009 issue of the Journal of Validation Technology.

“Auditor Tales” provides a forum for readers to share their auditing experiences—good or bad—and discuss how deficiencies were addressed. It is our hope that these discussions can serve as learning tools for others in the field. We welcome any thoughts, concepts, ideas, and experiences. Please e-mail your input to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

INTRODUCTION
During the many years I have performed inspections for clients, I have seen many instances of animals being where they don’t belong—on the manufacturing floor. Reflecting over my years of performing good manufacturing practice (GMP) audits worldwide, there have been many occasions that animal issues in pharmaceutical or in active pharmaceutical ingredient (API) manufacturing facilities have taught me lessons.

The following are some examples of such incidents, and I assure you that no single incident related here is from my imagination, nor is it exaggerated in any way. What you will read is what happened—exactly as it happened.

LESSON ONE: ISO 9000 IS NOT GMP
I was auditing a French API manufacturer and was standing in the second floor conference room waiting for some equipment qualification files to be delivered. Looking out of the window and admiring the skyline, I happened to look down into the company yard below where open reaction tanks were staged, each of which bore a green colored label stating “Propre”—French for “clean.” As I looked at the tanks, it started to rain, and I wondered how the company could claim the tanks were clean when they had been exposed to the elements and the rain.

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