Sterile Product Facility Design and Project Management: 2nd Edition (Hardback) book cover

Sterile Product Facility Design and Project Management

2nd Edition

By Jeffrey N. Odum

CRC Press

392 pages | 125 B/W Illus.

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Hardback: 9780849318740
pub: 2004-03-29
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pub: 2004-03-29
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Description

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices.

Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered.

Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

Table of Contents

Introduction to Facility Project Management

Project Formation

Defining the Project Team

Facility Programming

Project Control

Current Good Manufacturing Practice (cGMP): Project Impacts

Mechanical Systems

GMP Compliance in Architectural Design and Construction

Commissioning

Quality Management to Meet Regulatory Requirements

Establishment Licensing

Containment Basics

Multi-product Facilities for Biologics

Contract Formulation and Philosophy

Future Trends

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology