Shire

Background

The 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.

Objectives

  • Enhance regulatory compliance by updating current SOP.
  • Modify thermal packaging qualification to a ‘platform’ approach.
  • Establish warehouse, change control, and quality procedures.

Results

  • Mapped global logistics network, conducted  risk assessment and revised current SOP to match current approach.
  • Designed ‘platform’ qualification approach, assisted in RFP and validated pallet shippers.
  • New approach implemented, SOPs and assessments approved, standardized pack out SOPs made available globally.

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