Pharmaceutical Manufacturing
Research Project

Dear Visitors:

Welcome! This web page provides results from the Pharmaceutical Manufacturing Research Project (PMRP). The Pharmaceutical Research Manufacturing Project was launched in 2002. The project’s goals are 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.

The project was implemented in two stages. The first stage focused on FDA oversight of pharmaceutical manufacturing. The second stage focused on manufacturing performance of pharmaceutical manufacturing facilities. Throughout, this report will refer to the former as the “FDA Study” in the latter as the “Pharmaceutical Manufacturing Study”.

FDA Research Project

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 noncompliance. For instance, the statistical analyses show that some facilities were over inspected while other facilities were under inspected. Preliminary results of the FDA Study were presented to the FDA on January 28, 2005.

This powerpoint presentation with audio provides the initial report presented to the FDA on January 28, 2005. Within this presentation you will find:

• Executive summary
• Project goals
• Data collection and synthesis
• Analysis methodology
• Findings
• Development opportunities and constraints

Pharmaceutical Manufacturing Study

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). Unfortunately, only one biologic facility provided complete performance metric information so that we are unable to provide benchmarking data on performance for biologics. Nonetheless, data from this facility and other biologic facilities will be used in several of the statistical analyses. Manufacturers spent substantial effort collecting these data and entering it into a secure web site. We thank all participants for their generous efforts in collecting and entering these data. It is these data that are summarized and analyzed herein as a benchmarking report.

This pdf file cincludes an executive summary, 27 statistical summary of data provided by you and our other participants. Within this presentation you will find summary statistics on:

• Firm and Manufacturing Facility Overview
• Human Resource Management
• Product and Process Development
• Performance
• Deviation Management