Warehouse and transport qualification

This activity explores the definitions and objectives of transportation qualification, which aims to demonstrate the conformity of transport processes to pre-established specifications without compromising product quality. It presents the qualification methodology in four steps: risk assessment, qualification protocol development, testing, and results analysis. Learners will understand the importance of maintaining environmental conditions such as temperature and will learn to apply operational and performance qualification tests.

This activity focuses on user needs and the specifics of storage infrastructures. It describes the necessary tests to ensure uniform temperature distribution and precise metrology. Learners will learn to implement documentation management and continuous monitoring systems to maintain facility qualification. The chapter also emphasizes the importance of regular equipment calibration and communication among involved teams.

The activity presents a practical case outlining the steps required to ensure proper transport and storage of bioproducts. It covers the identification of temperature-sensitive products, selection of appropriate packaging, planning of low-risk transport routes, and application of storage procedures based on temperature zones. It also addresses how to manage delays and equipment failures to maintain product quality.