INTRODUCTION This chapter provides an overview of the regulatory requirements of current Good Manufacturing Practices (cGMPs) and describes the importance of cGMPs when designing engineering processes within a pharmaceutical facility….
5 Facility Utility Systems Jack C. Chu, Leonid Shnayder, and Joe Maida CONTENTS Introduction Production Facility and Utility Systems Design Must Follow GMP Practice Key Concepts Executive Summary Integrated Approach…
14 Containment Technology Hank Rahe and Brian G. Ward CONTENTS Introduction Defining Drugs in Terms of Contamination Risk Communication of Risk Risk Assessment by NIOSH and the European Medicines Agency…
18 Packaging and Warehousing John S. Holton CONTENTS Introduction Packaging Defined Importance of Packaging Packaging Functions Contain Function Protect and Preserve Function Transport Function Inform and Sell Function Levels of…
7 Commissioning, Qualification, and Validation Christina Meyer Dell Cioppia CONTENTS Introduction Executive Summary History of Validation Quality by Design Good Engineering Practice Project and Engineering Change Control Project Life Cycle…
13 Codes and Standards Eric Bohn CONTENTS Introduction Executive Summary Key Concepts Historical Background Zoning Codes Building Codes Other Standards Code Interpretation Role of the Design Professional Role of the…
3 Legacy Facility Master Planning Eric Bohn CONTENTS Introduction Executive Summary Key Concepts Definition of a Legacy Facility Legacy Facility Issues The Business Case for Legacy Facilities The Master Plan…
