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