Pharma Quick Reference Guide

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.

pharmaceutical-packaging-patient-safety-healthcare-supply-chain

Project Objectives

Based on the existing standards in place (CEIV, GDP, other) and the expertise coming from the Pharma.Aero projects and members, we aim to create a rapid guideline to be used for shipping TTSP to remote airports and/or located in an emergency geopolitical region in order to guarantee the minimal basic approach and make air transportation successful.

The deliverables would be a pre-flight checklist (capabilities, process times) as input to route planning and an arrival checklist for each involved stakeholders at an airport.

Timeline

June - August



Preliminary Research & Industry Insights

July - September

October



Framework Development & Qualification Mapping

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Industry Opinion Paper Publication

PROJECT
SUPPORT AND
COLLABORATION.

Pharma.Aero Board liaison: Brussels Airport
Project lead: Swissport
Project members: Expeditors, Hong Kong Airport, Qatar Airways, Astral Aviation, Pharma Shippers members of Pharma.Aero
Project external support: Martin Koehnke (external consultant)
Project manager: Céline Crahay, 3CeL (external consultant)

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