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

February 15, 2002

Barbara Unger

BioPharm International, BioPharm International-02-01-2002, Volume 15, Issue 2

Page Number: 14-18, 71

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.