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  • IVT Network - Gap Analysis Checklist For An Equipment-System-Facility Change Control Program - 2014-05-01

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    ApoloTrevino
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    A gap analysis checklist compares a company's current change control program for equipment, systems, facilities, and documentation against defined requirements. The checklist ensures all aspects of change control are considered, including changes to facilities, computer systems, documentation, training programs, and outsourced activities. A change control program formally documents and oversees any modifications that could affect the identity, strength, quality or purity of pharmaceutical products.

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    Within the complex facilities, utilities, and equipment (F/E/U) in a manufacturing plant, a line in the sand needs to be drawn between GMP-critical and business-critical. While the process for identification has been discussed before, the following are the differences between a GMP-critical and business-critical F/E/U, including the respective change management, taken from a Jorge Cordero presentation given at IVT’s Validation Week Canada.

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    IVT Network - Gap Analysis Checklist for an Equipment-System-Facility Change Control Program - 2014-05-01

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    A gap analysis checklist compares a company's current change control program for equipment, systems, facilities, and documentation against defined requirements. The checklist ensures all aspects of change control are considered, including changes to facilities, computer systems, documentation, training programs, and outsourced activities. A change control program formally documents and oversees any modifications that could affect the identity, strength, quality or purity of pharmaceutical products.

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    99 views1 page

    IVT Network - Gap Analysis Checklist For An Equipment-System-Facility Change Control Program - 2014-05-01

    Uploaded by

    ApoloTrevino
    A gap analysis checklist compares a company's current change control program for equipment, systems, facilities, and documentation against defined requirements. The checklist ensures all aspects of change control are considered, including changes to facilities, computer systems, documentation, training programs, and outsourced activities. A change control program formally documents and oversees any modifications that could affect the identity, strength, quality or purity of pharmaceutical products.

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    © All Rights Reserved
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    com)

    Gap Analysis Checklist for an Equipment/System/Facility Change Control Program


    By Miguel Montalvo May 1, 2014 7:59 am PDT

    Change Control is the implementation of, and adherence to, a formal process that documents any change to a
    (specified/qualified/validated/approved) piece of equipment, system, process or document that can affect the identity, strength,
    quality or purity of a drug product. The Gap Analysis is simply a comparison of the current system, its supporting
    documentation, and the people/resources qualifications/training against the defined requirements.
    This checklist ensures that all change control items; including change control in facilities, computerized systems,
    documentation, training, and outsourcing; are thoroughly accounted for during a gap analysis.

    Source URL: http://www.ivtnetwork.com/article/gap-analysis-checklist-equipmentsystemfacility-changecontrol-program

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