AbbVie

abbvie 

Background
AbbVie (http://www.abbvie.com) is a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe. It has the expertise of a proven pharmaceutical leader and still embodies the focus and passion of an entrepreneur and innovator. When it comes to innovating, AbbVie starts with the patient. They draw on their deep expertise in some of the most difficult-to-treat diseases as well as on their understanding of the patient journey in order to identify opportunities to create better outcomes at every stage. This patient-centered approach to discovery and development ensures they remain focused on the goal of improving lives.

    Objectives
    The quality management team identified the following objectives for this project:
    • Investigate the appropriateness of the current practice of combining refrigerated and room temperature materials in the same refrigerated 53-foot trailer
    • Define a loading pattern along with the required number and location of temperature monitors to best reflect the product temperature within the mixed-load trailer

    Value to AbbVie
    The value of this project identified by the quality assurance management team was multifold, including:
    • Help with ensuring compliance with cGMP/cGDP and MoH expectations for temperature control for refrigerated truckload trailers used during shipment of drug products
    • Assistance with the technical determination of the appropriateness of combining refrigerated and CRT products within the trailer

    Methodology
    Our approach to meeting the objectives was to:
    • Develop a technical report that justifies the current equipment and carrier selection based on the operating standard to address any immediate compliance concerns. (References to both the ATP and TMC standards were used.)
    • Establish an operating standard that requires carriers provide documented evidence that their equipment is capable of maintaining drug product within their respective thermal storage conditions. This operating standard must be included in all quality agreements with carriers.
    • Write three protocols: one for refrigerated, one for CRT, and one for mixed loads, which established the rationale for:
      • Loading proximity of palletized product to the walls of the trailer and to refrigerated/CRT pallets (including buffer distance between CRT and 2-8⁰C products)
      • Feasibility of double stacking (CRT vs. 2-8⁰C), including safety bars (load locks)
      • The number and placement of temperature monitors within the trailer for routine monitoring
    • Create a protocol template that could be executed in selected lanes for trailer thermal mapping during the anticipated seasonal extremes.
    • Write a technical report presenting the results of each of the protocols after execution of the three protocols.

    Results
    The progress toward the objectives was measured by the acceptance of the following deliverables:
    • Protocols to establish the number and location of monitor points within a truck for minimum and maximum loads for refrigerated, CRT, and combination loading
    • Protocol for thermal transport mapping of selected routes during seasonal extremes
    • Technical report to justify number and placement of temperature monitors
    • Updated standard operating procedures for trailer loading

    The data generated by the protocols provided enough documented evidence to the quality assurance team that the mixed-load trailers did not have an impact on the ability to maintain product-appropriate temperature during transport. The quality assurance management team approved a revised operating standard that approved use of mixed-load trailers with proper amendments to the carrier quality agreements, revised loading procedures, and specific retraining on load pattern requirements for operations personnel.