Security Standards

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 focuses on creating a robust, holistic security framework tailored specifically for the pharmaceutical industry, addressing the unique challenges posed by temperature-sensitive valuable products. This framework will provide a comprehensive set of guidelines and protocols to mitigate risks and ensure the secure handling, storage, and transportation of these sensitive items across four critical security pillars: Aviation Security, Customs Security, Asset Protection Security, and Data Security.

The Project will be run in 4 Work Packages with the following deliverables:

Work Package 1: Project Research
Standards definition and collection
Desk research on Aviation Security / Custom Security / Asset Protection Security / Data Security

Work Package 2: Member interviews

Project meeting (online) – September 2nd, 2024, Security Standards Survey Launch

Work Package 3: Workshop

Security Standards Workshop on Day 3 of the Pharma Logistics Masterclass, Dallas Fort Worth, October 2nd

Work Package 4: Dissemination

A comprehensive Technical Report presenting the project’s methodology and findings will be prepared and shared exclusively with Pharma.Aero members and partners. The project’s White Paper will be shared with a broader industry audience.

Timeline

June - August



Preliminary Research & Industry Insights

July - September

October



Framework Development & Qualification Mapping



Industry Opinion Paper Publication

PROJECT
SUPPORT AND
COLLABORATION.

Pharma.Aero Board liaison: Brussels Airport
Project leads: WFS
Project manager: Nicola Caristo, n21 Consulting (external consultant)
Project experts: Anne Julie Verhaeghe, Jeremy Xander, Jos Joos, KPMG (external consultants)
Project coordination: Sara Van Lerberghe, Pharma.Aero

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