1) Difference between reprocessing and reworking 2) Filing mechanism for manufacturing scale change 3) Heat Penetration Study for validation of depyrogenation tunnel 4) Define starting material 5) Do you know the ICH quality guidance documents? 6) Name the guidance documents that govern cGMP 7) Examples of process and product related impurities 8) Specific in vitro tests to determine the toxicological effects of product related impurities 9) Are you familiar with FDA's guidance on bispecific antibody development? 10) Hypothetical case - Assume that we have a product on the market with an established 24 month expiry period. During one of the ongoing stability studies, product degradation is observed at a 12 month time. What will be your approach to address this issue from a regulatory standpoint?
