TITLE

Animal Tales

AUTHOR(S)
Anisfeld, Michael H.
PUB. DATE
November 2009
SOURCE
Journal of Validation Technology;Autumn2009, Vol. 15 Issue 4, p20
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article discusses the lessons learned from animal issues in pharmaceutical or in active pharmaceutical ingredient (API) manufacturing facilities. Compliance to International Organization for Standardization (ISO) 9000 does not mean compliance to good manufacturing practice (GMP). Based on the author's experience, the more loudly a company proclaims that it is certified to ISO 9000, the poorer their GMP compliance profile. The author also learned to be precise when providing audit feedback and that there is always a hidden agenda when auditing a pharmaceutical company.
ACCESSION #
47337019

 

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