Activity

  • For a project we were working on it was a smaller part of a whole, which was analyzing viral clearance for a legacy product process. At first we did the initial research and looked through historical information within the company processes to see the logic and rationale behind the current process. We then created a rationale based on the research and information we found and contracted the studies to a international vendor since, BSE and TSE studies are not done in the United States. After finalizing the study and creating the protocol based off the manufacturing process we had to increase the project scope. This was a result of us receiving a video of the current process much later than requested (about one month later). When we actually analyzed the video of the process we realized that a key element in the process was not being done as described in the protocol and this may effect the experimental setup that was planned. This caused us to redo the finalized protocol and increased our timeline by about 2 months since it had to go through the round of approvals once again and we had to justify the reason for the change. In this situation we should have pushed harder to receive the video and assumed that it may not have been exactly as described since it was an external site we should have expected the worst case scenario.