5 Critical PUPSIT Considerations For Sponsors Targeting The EU Market

By Steve Taliadouros, Director, Manufacturing Science & Technology

If you are targeting drug product approval in the EU market, it is critical to ensure compliance with EU GMP Annex 1 guidelines. Annex 1 requires the use of pre-use post-sterilization integrity testing (PUPSIT), which is the process of performing filter integrity testing on sterilizing filters after sterilization is complete but immediately prior to sterile filtering of product. However, there are a number of misconceptions around the complexity, risks, and regulatory expectations surrounding PUPSIT; to protect your product, process, and compliance, familiarize your team with how PUPSIT works, why it is necessary, and how to mitigate risks.

Download the full article to explore a number of critical PUPSIT considerations for sponsors targeting EU approval, including the role of PUPSIT in a sterile manufacturing process, what regulators are looking for, clarity around common PUPSIT myths, and proven techniques for guaranteeing PUPSIT success.