Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection

Unger,Barbara;

Publication

Article

February 15, 2002

BioPharm International

BioPharm International-02-01-2002

Volume15

Issue 2

Pages: 14-18, 71

Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection

Author(s):

Barbara Unger

By Barara W. Unger, Don Hill Associates, Inc., pp. 14-18, 71. An effective, well-developed, and versatile preapproval inspection model focuses management and inspectors on conclusions, minimizes process reinvention, and tracks inspection readiness, especially when you are using a contract manufacturer.

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Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection

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