PUPSIT As Part Of A Contamination Control Strategy (CCS)

The implementation of pre-use, post-sterilization integrity testing (PUPSIT) has been the subject of long-standing discussion. The recent EU GMP Annex 1 revision reflects these discussions, incorporating data collected during this process. This update offers enhanced clarity on the topic, emphasizing the importance of quality risk management and regular review of the contamination control strategy. An essential aspect of this strategy is verifying the integrity of critical filters. Annex 1 has undergone multiple revisions, each update integrating technological advancements, improved understanding, and trends in the industry. The latest revision in 2023 introduces several changes, many of which aim to resolve ambiguities and update language to align with current technical and regulatory standards, including the requirement for PUPSIT. Keep reading to learn more about these changes and to gain insight into the components that should be part of a PUPSIT risk assessment.