Lilly

Background
The Lilly Supply Chain management team requested Modality Solutions review current vendor data, provide recommendations on shipping temperature sensitive (primarily 2-8°C) products via ocean containers, and ultimately validate the process. These ocean container shipments were piloted with double stack pallets of insulin to the Pakistan market in 40’ High-Cube ocean containers managed through Kuehne + Nagel freight forwarding services.

Objectives
The focus of the engagement was to combine key equipment, data and specifications essential for container qualification and shipping process validation. Using a bracketing strategy, the proper shipment was determined for these pharmaceutical products by:

  • Conducting a risk assessment of ocean shipping process
  • Compiling a technical assessment of manufacturer qualification process, testing data, and specifications to select the appropriately classed ISO container
  • Preparing a technical assessment of temperature sensitive (primarily 2-8°C) products for application to ocean shipping using protocols, data packages, and reports generated during product shipping validation
  • Creating a validation master plan based on identified risks and GDP/GMP regulations for ocean transport
  • Drafting a performance qualification protocol to test the selected ISO container based on the risk assessment and other expected operational extremes
  • Assisting in execution of performance qualification protocol
  • Completing a report on the results of the qualification protocol

Value to Company

  • The completion of the following deliverables helped determine measures of success:
  • A technical report assessing strengths and weaknesses of equipment testing data available from the manufacturer of equipment, steamship companies, and/or freight forwarders
  • Risk assessment of ocean transportation of temperature-sensitive drug products
  • Risk mitigation strategy for identified medium and high risks
  • Product testing strategy document for ocean transport of temperature-sensitive drug product
  • Validation master plan for ocean transport
  • Performance qualification (PQ) protocol and report for selected ISO container selected to ship temperature sensitive drugs worldwide

Methodology
The detailed approach on the assistance that we provided Lilly for risk assessment and gap analysis included:

  • Process maps were created to document both the shipping process and the monitoring and controls process for ocean transport. The maps focused on potential failure points, supplier quality management, and quality assurance testing. The maps were reviewed by Lilly management team for accuracy and were used to inform the risk assessment. 
  • A technical assessment of all vendor testing data and specification was compiled for review. This assessment focused on strengths and weaknesses of vendor approach to inform the risk assessment and prepare the validation master plan.
  • A risk assessment was conducted using appropriate techniques to identify and prioritize risks associated with the proposed ocean transport process including all available testing data and specifications reviewed in the technical report. The prioritized risks were used to inform the mitigation plan.  The entire risk assessment was documented in a risk assessment report.
  • The gate review of technical assessment of risk assessment was conducted to determine if ocean transport of insulin to Pakistan could be conducted as a concurrent performance qualification of ocean transport for temperature sensitive (2-8°C) products.
  • The ocean transport performance qualification was overseen.  The protocols developed to conduct ocean container OQ were closely monitored. (Note: Lilly contracted with appropriate third-party freight forwarders and testing facilities. Modality Solutions oversaw the execution of the PQ for the ocean transport.)
  • Risk mitigation strategies were determined. High and medium risks were evaluated along with temperature data collected during the concurrent PQ shipment of insulation to determine mitigation strategies. These mitigation strategies were detailed in the risk assessment report.
  • A risk assessment report was created. A report detailing the assessment of findings with a qualitative measurement of finding (i.e. critical, major, or minor) was written for the Lilly management team.
  • The product testing technical assessment was developed. Current product shipping validation approach and technical data were used to review and compare against the risks. A product testing strategy focused on confirming chemical and physical stability for ocean transport. Protocol and report templates for product testing are included in the product testing strategy.
  • Finally, the validation master plan based on identified risks and GDP/GMP regulations was created. This validation master plan details the approach, risks, vendor data, and the expected results from OQ and PQ execution. The validation master plan also includes the protocols and reports required to execute all required qualification work.

Results
The Modality Solutions management team was able to effectively accomplish this validation process for Lilly Supply Chain by incorporating equipment operational qualification, test data, and vendor specifications. Using a bracketing strategy, both the container qualification and shipping process validation were successful through the development of an approach for NALO that included the selection and qualification of ISO containers for ocean shipment of temperature-sensitive pharmaceutical products.