SYMPOSIA PAPER Published: 01 January 1996

Commissioning Major Pharmaceutical Manufacturing Facilities


Commissioning is the planning, coordination, management, and execution of activities that form the bridge between the construction phase and the operation and maintenance phase of a facility life-cycle. Commissioning helps demonstrate the facility works properly and establishes systems for reliable operations and maintenance. Validation is a major part of the overall commissioning process. Substantial savings are possible in terms of costs and schedule through more effective coordination of commissioning activities. Benefits of a coordinated approach include: • Increased confidence that facility meets intended requirements (e.g., GMP, safety, environment, production capacity,) • Eliminating waste through duplication • Providing for consistent and efficient commissioning • Quicker achievement of successful initial operations

Author Information

Fay, ST
Performance Solutions, Inc., Indianapolis, IN
Howard, TP
Performance Solutions, Inc., Durham, NC
Stevens, WT
Performance Solutions, Inc., Prospect, KY
Price: $25.00
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Developed by Committee: E48
Pages: 3–13
DOI: 10.1520/STP14705S
ISBN-EB: 978-0-8031-5322-6
ISBN-13: 978-0-8031-2405-9