Section F - What Went Wrong? (5 points) You should be able to answer this question in 1-2 paragraphs. As with everything else, you are graded on the thoroughness and thoughtfulness of your answer - if you answer with only a handful of words, it cannot typically earn full credit in comparison to the work of other students, unless they are somehow absolutely comprehensive of the answer. Context: A drug manufacturer was excited when their supplier installed for them a brand new, state-of- the-art vacuum drying oven. The supplier handed over the user manual and factory testing paperwork, and declared the oven ready to be qualified. The drug manufacturer reviewed and approved the OQ protocol that the supplier provided them, and then ran the tests without any major incident. After a few experimental tests were performed, the drug manufacturer prepared, approved, and ran a performance qualification (PQ), again with satisfactory results. By way of process validation, three consecutive batches were dried and tested to ensure they met water content specifications. The first batch of product met specifications, but the second and third did not - they were too wet and required reprocessing (more drying). The manufacturer opened this as a Deviation for failure to meet acceptance criteria, and conducted an investigation. They determined that when the vacuum motor was installed, oil had not been added to the motor, and the factory lubrication was wearing thin, causing the motor to work less efficiently, and creating insufficient vacuum to dry properly. Their Maintenance Department added oil under Work Order, and with the problem thus corrected, all three process validation runs were repeated, this time successfully. Question: Did this drug manufacturer do anything wrong, or at least not according to best validation practices, that led to this unfortunate result, or did something go wrong despite doing all the right things? Why or why not? What, if anything, would you have done differently? Justify your