Features of Sterile Product Facility Design and Project Management:

• Breaks the project process into four phases: formation, design, execution, and implementation
• Explores each project phase from the Project Manager's viewpoint
• Describes technical issues in clear detail, with many illustrations, diagrams, and photographs
• Covers the manufacturing of biopharmaceuticals in a GMP environment

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.

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

Index

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