Medical Devices Regulations

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

The project, Balancing Innovation and Regulations: from Care to Air, is intended to engage Pharma.Aero community to:

Understand the implications of the regulations on the logistics supply chain operations of Medical Devices.
Confirm if the changes require any specific certifications from the logistics supply chain partners and manufacturers.
Identify variations (if any) from the current EU GDP regulations and how they will impact existing framework.

The project consists of 4 Work Packages:

Work Package 1: Mobilization of stakeholders and conduct kick-off session
Work Package 2: Assessment and information gathering through desk research
Work Package 3: Workshops with designated stakeholders and guideline creation
Work Package 4: Publications (Technical Report and White Paper)

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: GRU Airport, Zoetis
Project leads: Expeditors, Qatar Airways
Project manager and expert: Morgane Franck, PwC (external consultant)
Project coordination: Sara Van Lerberghe, Pharma.Aero

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