Reference no: EM133210413
1. Which of the following is true when comparing GMPs and QSRs:
a. The QSRs were written before the GMPs
b. Both the GMPs and the QSRs require adequate number of personnel
c. Both the GMPs and QSRs require a formal management review of quality system
d. Both the GMPs and the QSRs require design controls
2. Which of the following is a significant difference (from a GMP perspective) between gene therapy, such as Zolgensma, and cell therapies, including genetically modified cell therapies such as CAR-T:
a. Gene therapy products are not tailored to specific patients and can often be produced in a more traditional batch manufacture
b. Cell therapy products must be produced under aseptic conditions while most gene therapy products do not need to be free of adventitious organisms.
c. Cell therapy products often need to be released "at-risk" because the patients require immediate treatment and there is not time to wait on results from long lab assays. Most gene therapy products are not patient specific and can usually be stocked in advance so they are not released until all testing is completed and reviewed.
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