In 2002 the FDA commissioned a comprehensive study. Initially the results were only presented to the FDA. Now the authority made them public – dated September 2006.

Goal of the study was

"to investigate the effects of production technology, product technology, manufacturing site location, firm reputation and experience, and the organizational structure and incentives of pharmaceutical manufacturing on the likelihood and type of enforcement efforts utilized by the FDA. By studying these relationships, the project's desire is to generate new insights into the strategic management of pharmaceutical manufacturing, as well as to offer new insights into strategies for improving product and workplace safety in this and other industries.

Working with the FDA, the project team collected a wide range of FDA confidential data. While a confidentiality agreement prohibits the release of these data, results from statistical analyses are publicly available. Data collected came from the FDA's Field Alerts, Inspections (FACTS), Product Listing, Facility Registration, and ORA training databases. (Additional data involving product recalls, product shortages, and warning letters also were collected but have not been fully integrated into the statistical analyses.) With this information, the team developed statistical models that predict the probability of a facility being chosen for inspection. Models were developed to evaluate the effect of investigator training and experience on the probability of investigational outcomes as well as individual investigator effects on the probability of investigational outcomes. Finally, the project identified characteristics of facilities and firms that correlate with the likelihood of non-compliance. For instance, the statistical analyses show that some facilities were over inspected while other facilities were under inspected.

Working with 19 manufacturers, the project team collected data on 42 pharmaceutical manufacturing facilities for the Pharmaceutical Manufacturing Study. Data collection included information about the firm and the manufacturing facilities; human resource management, the management of deviations, the use of various teams, shop floor performance metrics, process development metrics, and regulatory performance. Types of facilities include oral and topical manufacturing facilities (22 in all), injectable manufacturing facilities (eight in all), active pharmaceutical ingredients (API) manufacturing facilities (15 in all), and biologic manufacturing facilities (five in all)."

The study will be an essential foundation for the future FDA GMP compliance strategy. For that reason the comprehensive data and the derived consequences are highly interesting for everybody involved in cGMP compliance.

The complete study can be downloaded here: http://www.olin.wustl.edu/faculty/nickerson/results/PMRPFinalReportSept2006.pdf

Compiled by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)