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AUDITOR TALES: Animal Tales
Author: Michael H. Anisfeld

“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.

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