As biopharmaceutical products are supplied to multiple countries, post-approval CMC changes may be delayed by differences in classification, requirements, approval timelines, and implementation timing. Plasma-derived medicinal products are process-dependent products made from human plasma, with risks related to plasma variability, infectious hazards, donor screening, NAT, look-back, and traceability. Process changes may affect quality attributes and viral clearance capacity, so comparability and viral safety impact should be assessed together. This study compared MFDS, FDA, and ICH requirements using regulatory document review, comparative analysis, and GAP analysis, focusing on plasma source, processes, E&L, aseptic processing, CCI/CCIT, and timing. All frameworks required evidence that CMC changes do not adversely affect quality, safety, or efficacy, but differed in reporting categories, data requirements, and implementation. Source plasma and plasma pool changes should be treated as viral risk profile changes and supported by risk assessment, NAT sensitivity, marker trends, look-back, and traceability data. Fractionation/purification and viral inactivation/removal changes require comparability data and, when needed, viral clearance validation and robustness data. Product-contact and aseptic filling changes require E&L, CCI/CCIT, sterility assurance, and stability data. This study proposes a framework for comparability, viral safety, sterility, and implementation.