Every temperature-sensitive pharmaceutical product relies on qualified packaging solutions to maintain its integrity throughout transportation. Yet, across the industry, qualification tests are frequently repeated by different organisations, even when reliable supplier-generated evidence already exists.
The new Pharma.Aero Industry Opinion Paper examines why this duplication persists and how a more harmonised, risk- and science-based approach could reduce unnecessary testing without compromising regulatory compliance, product quality or patient safety.
Developed through extensive industry consultation, including a stakeholder survey, structured interviews and a review of regulatory and industry guidance, the Packaging Qualification Integration Project brought together perspectives from pharmaceutical manufacturers, packaging providers, freight forwarders and ground handling agents.
From Repeated Testing to Trusted Evidence
The findings suggest that the main obstacles to reusing qualification evidence are not technological. Instead, they relate to differences in testing parameters, inconsistent terminology and the absence of agreed governance frameworks for assessing and relying on evidence generated by other organisations.
The paper identifies five essential conditions for trusted evidence reuse, and explores how existing regulatory approaches can support greater use of supplier-generated evidence, provided that appropriate controls are maintained and qualification decisions remain the responsibility of the pharmaceutical company.
A Call for Industry Alignment
The publication argues that meaningful progress will require collective action rather than individual initiatives. It outlines opportunities for industry stakeholders to work towards harmonised testing conventions, consistent supplier evidence packages and shared governance principles. Engagement with regulators and standards bodies will also be essential to establishing approaches that can be applied across different markets.
The central message is clear: the next advance in cold chain packaging qualification will come from trusted evidence, not new technology.
With the publication of this Industry Opinion Paper, Pharma.Aero invites pharmaceutical manufacturers, packaging suppliers, logistics providers, standards organisations and regulators to contribute to the next phase of the Packaging Qualification Integration initiative.
The project was developed, coordinated and managed by Pharma.Aero, with contributions from industry experts and stakeholders across the pharmaceutical supply chain.