Data Integrity applied to product batch release

This activity presents the key stages in drug development and the batch release process, illustrated by a data collection example during vaccine manufacturing. It introduces the principles of compliance, responsibilities, and operations involved in product release.

This activity presents the regulatory requirements for product release, including Good Manufacturing Practices (cGMPs) and the seven data-related requirements outlined in EU Annex 16. It explores the connection between data and batch certification, highlighting their critical role in product recalls.

This activity presents a series of practical scenarios highlighting data integrity issues in the context of batch release, including data entry errors, technical decisions in IT, data loss, and deviations identified during quality review. It enables analysis of the impact of such situations on documentation compliance and batch release decisions.