STP1260

    Commissioning Major Pharmaceutical Manufacturing Facilities

    Published: Jan 1996


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    Abstract

    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

    Keywords:

    Validation, commissioning, scheduling, startup, testing, planning


    Author Information:

    Fay, ST
    Senior Engineer, Performance Solutions, Inc., Indianapolis, IN

    Howard, TP
    Senior Engineer, Performance Solutions, Inc., Durham, NC

    Stevens, WT
    President, Performance Solutions, Inc., Prospect, KY


    Paper ID: STP14705S

    Committee/Subcommittee: E48.03

    DOI: 10.1520/STP14705S


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