Situation Appraisal 

Shire Pharmaceuticals focuses on attention deficit hyperactivity disorder (ADHD), human genetic therapies, gastrointestinal diseases, regenerative medicines, and explores opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire’s formulations for the Specialty Pharmaceutical division are in form of solid dosages. Their controlled room temperature (CRT) thermal packaging qualification process for their sold oral dosages needed reevaluation to confirm they met new regulatory expectations within the current channels of distribution. The current approach was not scalable and may not support planned product/country registration plans. 

The focus of the CRT thermal packaging qualification process redesign for Shire was to:
  1. Enhance regulatory compliance by updating current SOP that is currently utilized for thermal packaging qualification, transport lane qualification, and thermal packaging performance qualification for product licensing/registration.
  2. Modify the current thermal packaging qualification to a ‘platform’ approach that allows for quick integration of new products and countries being added to Shire’s portfolio and geographic coverage.
  3. Establish warehouse pack out procedures, change control, and quality management system procedures for the thermal packaging in the distribution centers globally.


Short-Term Improvements 

The short term improvements focused on improving "inspection readiness” for inter-site shipments of both bulk and finished goods in pallet quantities. The goal was to ensure all current transport lanes and pallet shippers used to supply drug product in the logistics network were mapped, assessed, and an approach for verification was documented in the quality management system.
  1. Map logistics network. A map of the current and projected logistics network were developed based on product launch strategy. This logistics network map drove the thermal profile selection process, identified types of thermal packaging to be qualified (e.g. small parcel, pallets, or active refrigeration, etc.), and informed the thermal packaging qualification process design.
  2. Conduct risk assessment. The current thermal qualification data, logistics network, and regulatory guidance were assessed with a proprietary HAZOP tool developed by Modality Solutions to identify opportunities to reduce regulatory exposure and to guide short-term process improvements.
  3. Manage change control. Change control records were created to manage the planning and control of revisions to thermal packaging qualification, process parameters, and procedures to prevent unintended consequences.
  4. Revise current SOP to match current approach. Current SOP were reviewed to identify enhancements required to match current approach followed in current protocols and reports to data are collected in the shipping lane verification studies.
  5. Enhance the draft technical assessment for current thermal shippers. Current thermal packaging qualification were enhanced by completing a technical assessment of current documentation to justify current qualification data. This technical assessment was used to support the use of the current thermal shippers for monitored shipments.

Long-Term Improvements 

The long-term improvements were designed to make global expansion of new products and new markets possible by providing a scalable approach. A ‘platform’ approach for shipper qualification was designed for all current shippers, both inter-site pallet shippers and small parcel shippers used at distribution centers, will be evaluated against the new approach.
  1. Design ‘platform’ approach to thermal packaging qualification process. The current SOP was replaced with a ‘platform’ approach to thermal packaging qualification. Three separate SOPs were created: Thermal packaging qualification, Transport lane qualification, and Transport performance qualification (PQ)
  2. Assist in the small parcel thermal packaging request for proposal (RFP). The ‘platform’ approach to thermal packaging qualification process was aligned with the on-going request for proposal (RFP) to ensure the proper operational qualification (OQ) data package was prepared by prospective suppliers. If the provided OQ data was considered unacceptable, a gap analysis was conducted to determine remediation steps.
  3. Validate the pallet thermal packaging systems. The small parcel shippers selected in the Request for Proposal (RFP) were validated. Operational qualification of shippers according to Shire’s new qualification program was required by the selected vendor (Softbox). Modality Solutions supported Shire in execution of the performance qualification (PQ) portion of the validation process.
  4. Create pack out SOPs for current thermal packaging solutions. The thermal packaging systems required a pack out SOP for each package. These SOPs were used to uniformly train warehouse personnel to correctly pack out the new packaging systems.
  5. Design monitoring and controls system. The validated thermal packaging system required monitoring and controls system to ensure proper maintenance of the validated cold chain. The monitoring and controls system design identified the appropriate technology, use and placement, and management review required to ensure compliance to cGDP requirements.


In 2013, the Shire GDP Team with the assistance of Modality Solutions developed and implemented a new temperature controlled shipper qualification process to evaluate and select a preferred global supplier of CRT shipping solutions.
  1. New ‘platform’ approach to thermal packaging qualification is implemented.
  2. Document changes, technical assessments, and validation approach are reviewed and approved in the quality management system to support regulatory inspections.
  3. CRT thermal packaging solution was selected and validated with documentation package is available and a standardized pack out standard operating procedures (SOPs) are available for all internal and third-party distribution centers globally.