PUPSIT and the annex one revision

This article presents an update on the efforts of the joint PDA and BioPhorum collaboration workstreams—masking studies, historical data mining, filter manufacturing and use risk assessments and PUPSIT risk assessment and the development of a best practice guide. The conclusions are:

1. Companies and regulators should use a nonbiased risk-based approach drawing on scientific evidence from objective data when making decisions related to the feasibility and validity of controls to prevent aseptic process failures. That effort should be commensurate with process, product and patient risk.

2. Where little to no scientific evidence or data is available, that should be a signal to industry and regulators to obtain or develop the missing evidence. Where the evidence supports or promotes prescribed or alternative approaches that are beneficial, or even more suitable, for the process/product in scope, those approaches should be considered and adopted.

3. Where evidence is presented, results published and positions offered, industry leaders, suppliers and regulators should welcome commentary and discussion on how to best interpret and communicate these results.