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.

To view a PDF of this article from the BioPharm International archives, click this link

Articles in this issue

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

Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar

Outsourcing Outlook: Reaping the Benefits of E-Procurement

The Immunogenicity of Therapeutic Proteins

Analytical Advances: Calibration Management of Outsourced Calibrations

High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!

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

Newsletter