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Shire

Creating a Cost-Effective, Regulatory Compliant CRT Cold Chain

Challenge

Shire asked Modality Solutions to re-evaluate their controlled room temperature (CRT) thermal packaging qualification process for their oral dosages to confirm they met new regulatory expectations.

Objectives

  1. Develop a supply chain map, process flow diagram, and technical report
  2. Enhance regulatory compliance
  3. Modify thermal packaging qualification to a ‘platform’ approach
  4. Establish pack-out procedures, change control, and quality management system

Results

Discover how Modality Solutions developed and integrated a new CRT approach that was more scalable and supported planned product/country registration plans.

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