CEIV 2.0 Phase 1: Evaluation

Relevance

Packaging qualification is a critical element of pharmaceutical quality and patient safety, ensuring medicinal products remain protected throughout storage, handling, and distribution. As supply chains become more global and complex, life sciences organisations face growing pressure to accelerate time-to-market, control costs, and improve efficiency while maintaining regulatory compliance. Yet current qualification practices often involve significant duplication of effort, with pharmaceutical companies repeating activities already performed by qualified packaging suppliers, while valuable supplier-generated performance and transport data remains underutilised due to concerns around standardisation, traceability, and regulatory acceptance.

GOAL

The Packaging Qualification Integration (PQI) project explores whether supplier-generated qualification data can be integrated into pharmaceutical packaging processes under appropriate quality and governance frameworks to reduce redundancy, shorten qualification timelines, and strengthen supply chain collaboration without compromising quality, compliance, or patient safety.
Through industry research, workflow analysis, stakeholder interviews, and the development of an industry opinion paper, the project seeks to assess the feasibility of this approach and stimulate informed discussion on more efficient, collaborative, and sustainable packaging qualification practices across the life sciences and logistics industries.

Project Objectives

The aim is to obtain the latest industry view on CEIV Pharma and be able to share the recommendations with IATA  to raise awareness of the program and engage shippers in the value of CEIV which should aid them in lane assessment, reduction in audit frequency and complexities.

Timeline

June - August

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Preliminary Research & Industry Insights

July - September

October

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Framework Development & Qualification Mapping

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Industry Opinion Paper Publication

PROJECT
SUPPORT AND
COLLABORATION.

  • Pharma.Aero Board liaison: Brussels Airport Company and Changi Airport Group
  • Project leads: Dnata
  • Project members: 38 members respondents to the survey (WP1), +40 Pharma.Aero members and partners involved in the problem-solving sessions organized in collaboration with IATA (WP3)
  • Project expert (Phase 1, WP1): Aynur Rasulova-Rzepa, Rzepa Consulting Limited (external consultant)

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