Operational Control in Temperature-Sensitive Transport: Key Q&A Insights (Part 3)

Following the ECA Live Online Training on Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification, participants raised many practical questions. After the session, experts provided written responses, and selected highlights are shared here for wider reference. This final installment focuses on operational control, contingency planning, and periodic review.

Not all packaging components are single-use. While thermal liners are often discarded due to hygiene and damage risks, cool packs or PCM bricks may be reused if proper inspection, cleaning, lifecycle tracking, and qualification procedures are in place.

For road transport emergencies such as vehicle breakdowns or accidents, GDP expectations require predefined contingency measures. Large organizations typically maintain SOPs covering replacement vehicles, product transfer, or temporary storage.

Periodic reviews have no fixed regulatory timeline, but annual evaluations of performance, calibration, and maintenance are considered best practice, with requalification after major changes.

X-ray screening is mainly used for security in air freight and generally poses no risk to product quality.

For passive shipping systems, qualification time usually starts at pack-out, unless approved, tested hold times are defined.

26-01-2026