PDA Survey: 2025 PUPSIT Benchmarking Survey

The scope of this survey encompasses the evaluation of industry practices, challenges, and perspectives related to the implementation of the PUPSIT requirement as outlined in Annex 1 of the EU GMP Guide, effective August 2022. The survey targeted professionals and organizations involved in sterile drug manufacturing, including pharmaceutical, biopharmaceutical, and contract manufacturing operations.

It gathered information on:

• The manufacturing location and distribution of the medicinal products
• Whether these products are aseptically filled
• The current status of PUPSIT implementation in existing and new processes
• If not implemented, will it be implemented
• Any risk assessment activities and regulatory interactions
• The perceived complexity and associated risks introduced by PUPSIT
• Test methodologies and performances
• Pre-use integrity test failures and the root causes
• Microbial contamination findings potentially related to PUPSIT

By focusing on these key areas, the survey aimed to provide a comprehensive overview of how the requirement is being addressed across the industry and to identify both common practices, alternative approaches and experiences with risks and risk assessments.