Creating a Cost-Effective, Regulatory Compliant CRT Cold Chain
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.
- Develop a supply chain map, process flow diagram, and technical report
- Enhance regulatory compliance
- Modify thermal packaging qualification to a ‘platform’ approach
- Establish pack-out procedures, change control, and quality management system
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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