For a pharma company, determining the relative GMP quality risks at company manufacturing sites and at partner CMOs 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 risk for a manufacturing site is based on many factors, some obvious and others subtle. For example, a “for cause” inspection would signal more agency concerns at a site than a routine surveillance inspection, as would a lengthy inspection vs. a short one. Findings on product sterility vs. on employee training or repeat observations from previous inspections could also indicate higher risk. This presentation will go through a methodology used to produce a site risk analysis, including how to determine the risk factors, how to categorize them as critical (red), major (orange), or minor (yellow), and how to evaluate the signals over time. Included will be a case study of a pharmaceutical site for which the inspection history taken together could have predicted a recent egregious inspection and the subsequent warning letter the company received. It will also explore why some inspections do not detect issues while others find serious issues.
Learning Objectives:
Determine the quality risk factors for a manufacturing site using publicly available information.
Combine risk factors to produce a compliance picture of a manufacturing site.
Understand how to use that information to inform improvement efforts and perform due diligence for current and potential partners.
Learn how to use that information to assess the GMP Health of manufacturing sites in your own company.
