Case Study applied to bioproduction facility operation

This activity presents the fundamentals of Good Manufacturing Practices (GMP) and the responsibilities related to preparing for a quality audit in a GMP-regulated environment. It also covers HSE (Health, Safety, and Environment) requirements and the key checks to be carried out in the production area to ensure safety and regulatory compliance.

This activity places the learner in a simulated environment to manage two deviations: an acid spill in the DSP area and an out-of-specification conductivity during a purification step. It involves the use of analysis tools (5M, 5 Whys), the criticality matrix, and the full deviation management process leading to a CAPA plan.

This activity simulates two new quality deviations: a non-compliant chromatographic profile and a contamination during the inoculation step. The learner is tasked with identifying root causes, analyzing quality impacts, and implementing concrete corrective and preventive actions.