Tony.Moorcroft@CQ-Technology.com

+1  860-753-0179

Commissioning and Qualification

  • System/equipment startup and shakedown -

    Manages the workflow, performs checks, and reviews documentation.

    The controlled release of electrical power and mechanical fluids to setting equipment and systems into operation and subsequent troubleshooting activities.

  • Instrument checkout and loop checks -

    Oversees the workflow, performs checks and reviews documentation.

    An activity performed to verify correct instrumentation connectivity and control functionality.

  • Instrument calibration -

    Oversees the workflow and reviews documentation.

    An activity comparing an instruments ability to produce results within specified limits and over an appropriate range when compared to a reference or traceable standard.

  • Automation checkout -

    Manages the workflow, performs checks and reviews documentation

    An activity performed to assure that the automation functions with the equipment in accordance with the design specifications and include the following.

  • HVAC and hydronic system balancing -

    Manages the workflow, performs checks and reviews documentation

    An activity performed to ensure air and water flow rates are adjusted and set to design values to achieve design environmental conditions and design room airflow direction/pressurization.

  • Operational testing and equipment/automation site acceptance testing -

    manages the workflow, performs checks and reviews documentation

    Activities performed at the project site demonstrating and documenting that the equipment item and/or automation has been integrated in to the project work site and functions to specification.

  • Qualification protocol execution -

    manages the workflow, performs checks and reviews documentation

    The execution of cGMP IQ/OQ/PQ protocols to verify that (a) the equipment or systems, as installed or modified, comply with the approved design, the manufacturer's recommendations and/or user requirements; (b) that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges; and (c) that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based.

  • Transfer of Care Custody and Control -

    manages the workflow and prepares documentation

    The mechanism and workflow process by which equipment, systems and functional areas are ownership transferred from the Project to the Operational site.

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Tony Moorcroft

avatar Tony brings to the table a blended strategy based on ASTM E 2500-07 (Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) and the ISPE Commissioning and Qualification Baseline Guide - with a career exclusive in ... [Read More...]