Predicting GMP Quality Risks at Manufacturing Sites

For a pharma company, determining the relative GMP health of your manufacturing sites and of your CMO sites is a key element of quality risk management and continuous improvement and a key part of due diligence when evaluating potential GMP partners. Evaluation of the GMP health of a manufacturing site is based on many factors, some obvious and others subtle. This presentation will go through a methodology that uses publicly available information and produces a site risk analysis, including what the risk factors are, how to determine them, how to categorize them as critical, major, or minor, how weigh them to produce a composite score, and how to evaluate the signals over time. Included will be case studies of three pharma company manufacturing sites. It will also explore why some inspections do not detect issues while others at the same site may find serious issues.