Content focuses on validation and continued control of pharmaceutical and medical-device shipping processes. Topics include distribution-risk assessment, shipping-validation strategy, route and lane qualification, actual shipment studies, excursion assessment, product disposition, carrier and logistics controls, change management, performance trending, periodic review, and risk-based requalification.
Shipping validation establishes documented evidence that a defined distribution process can protect a regulated product from conditions capable of affecting its quality, safety, identity, strength, sterility, functionality, or other required characteristics between release from the shipping site and receipt at…
Shipping lane qualification establishes documented evidence that a defined transportation route and logistics process can operate within the conditions assumed by the overall shipping-validation strategy. The objective is not simply to demonstrate that several shipments arrived successfully. A lane study…
A shipping excursion occurs when a distributed product is exposed to conditions outside the approved or otherwise defined transportation limits established for the product and shipping system. Temperature excursions are the most common example, but distribution deviations can also involve…
Shipping validation remains valid only while the product, packaging system, distribution routes, environmental controls, monitoring strategy, logistics providers, and operating procedures continue to operate within the assumptions established during qualification. Because commercial distribution systems change frequently, lifecycle control is essential…