Standard Operating Procedures in Cell and Gene Therapy Manufacturing

This capstone project conducted a structured literature review to analyze how Standard Operating Procedures (SOPs) are used to ensure Good Manufacturing Practice (GMP) compliance in the manufacturing of cell and gene therapies. The primary objective was to compare regulatory expectations and enforcement practices between the U.S. Food and Drug Administration (FDA) and Health Canada, with a focus on identifying gaps, best practices, and implications for regulatory alignment. By synthesizing data from peer-reviewed studies, regulatory guidance documents, and inspection reports, the project aimed to highlight the central role of SOPs in maintaining product quality and patient safety, while exploring how jurisdictional differences in regulatory oversight may influence the consistency and rigor of SOP implementation.