This slide is from a training I did on biologics development, GMPs and Quality. It shows that the Quality System evolves over time depending on what phase the biologic is in its development. This is one of the main challenges I help clients with—determining the appropriate level of GMP controls for clinical trial phase production. For example, most folks know that process validation is not required for clinical trial phase production, but quality systems procedures for deviations is required. Looking at the slide, we see that it is typical to just have some SOPs and a batch record in place for pre-clinical production of material for pre-clinical studies, and possibly a very bare bones quality system. Then for phase I clinical trials, a basic quality system is typically in place, with most methods partially qualified, most all SOPs in place. The phase I Guidance from FDA is the standard in the US. For start of commercial, a good quality system should be in place, all SOPs needed for production and quality, and all equipment and methods qualified. Process Validation is completed for the BLA, continuous improvement is being done, and the goal is approval and a successful PAI. In this regard, I often help clients with commercial readiness and PAI readiness. For routine commercial production, the emphasis is on continuous improvement, routine inspection readiness, integration of changes, with emphasis on efficiencies, deviation and CAPA management. With a mature quality system, there are often numerous SOPs and an emphasis on efficiencies, CAPA effectiveness, quality systems (IT systems), and process improvements.