Sterile filtration QRM & Pupsit
What do you think when you hear PUPSIT?
In Video 1 sterile filtration subject matter experts from AstraZeneca, Biogen, J&J, Eli Lilly, and GSK explain what PUPSIT is, the difference between a PUPSIT and non-PUPSIT systems, the regulatory expectations on PUPSIT, and their thoughts on the subject.
In Video 2 sterile filtration subject matter experts from AstraZeneca, Biogen, Sartorius Stedim, Sanofi and Eli Lilly explain how PUPSIT relates to filter flaw masking and elaborate on their conclusions from the SFQRM Consortium studies on the subject.
In Video 3 sterile filtration subject matter experts from GSK, J&J, Biogen, Eli Lilly, and Sanofi discuss the practical implications and decision making of PUPSIT answering questions such as “what product and product characteristics could increase risk of masking?” and “how do companies know if their product is vulnerable to filtration failure?”.