In March of 2017, PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. Due to increased enforcement of section 113 of Annex 1 by European regulatory agencies, manufacturers of sterile medical products are finding they must modify their manufacturing processes to incorporate the PUPSIT and/or are not able to justify its exclusion on risk-based principles. The survey was open to PDA members with subject-matter expertise in PUPSIT and who hold the manager level position in biologic process development, manufacturing, validation, and/or quality. Readers are encouraged to draw his/her own conclusions from the presented summarized data and responses.
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Questions and Answers