GMP Compliance Trends: An Industry Perspective Mitchell W. Manning Priorities Limited

GMP Compliance Trends: An Industry Perspective Presentation Context: Current Compliance Issues for Pharmaceuticals and Devices Presentation Sources: -FDA.gov- Wall Street Journal -ASQ- Fortune -ISPE- Harvard Business Review -PDA- Burrill & Company -Internet- Interviews Presentation Disclaimer: The information and opinions expressed by the presenter are intended for general training and educational use of the conference audience and are not intended as official positions of the ASQ/FDC-FDA.

GMP Compliance Trends: An Industry Perspective Trend One: GMP Compliant Manufacturing by Design Trend Two: Partnering With the Regulators Trend Three: Outsourcing Compliance Leadership Trend Four: Risk Management of Compliance Trend Five: Compliance through PAT Trend Six: Multiple Compliance Requirements Trend Seven: Going Global Trend Eight: Going High Tech Trend Nine: Risk Management of GMP Inspections Trend Ten: Over-committing and under-performing Trend Eleven: GMP Compliance to GMP Quality Trend Twelve: Risk Taking before Risk Management Trend Thirteen: Rx GMPs preferred over Dx GMPs

GMP Compliance Trends: An Industry Perspective Trend One: GMP Compliant Manufacturing by Design

Integrated Quality System DesignExecuteMonitor/Control Design – determine what is really important Execute – translate into manufacturing Monitor/Control – translate into quality assurance Continuous Improvement

Process Control and Capability Cycle Development History Technical Evaluations process and productQuality (GMP) Evaluations quality systems Integrated Validation Master Plan processproductsystems Change Control process and productChange Control quality systems Process Flow Document Technology Transfer Qualification Validationprocess and product Execute, Monitor and Control Quality Management System Begin with the End in Mind 1.Compliant 2.Capable 3.Robust 4.In Control 5.Continuously Improving Establish shared standards and expectations Execute and monitor with best business practices. Assess results against the standards and practices. Document with GMPs in Mind 1.Clear 2.Concise 3.Correct 4.Complete 5.Confident

GMP Compliance Trends: An Industry Perspective Trend Two: Partnering with the Regulators Drug Pipeline Globalization Bioterrorism Counterfeit Drugs and Devices Pandemics GMP Complexity Personalized Medicine

Burrill's Predictions for Biotech in Biotechnology will continue to fuel a major transformation in healthcare -- one that emphasizes earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. A reasonably robust public equity IPO market in the U.S. in 2006 and even a larger number internationally. More pricing pressure -- managed care, CMS, various country health ministries The trend towards Mergers and Acquisitions will continue with substantially more deals than 2005, especially among the larger companies. Similarly, we will see more and larger partnering deals with an emphasis towards discovery stage deals. Drug safety issues will be high on the agenda and approvals will be tougher to obtain. The trend towards personalized medicine will accelerate.

GMP Compliance Trends: An Industry Perspective Trend Three: Outsourcing Compliance Leadership

GMP Compliance Trends: An Industry Perspective Trend Four: Risk Management of Compliance

GMP Compliance Trends: An Industry Perspective Trend Five: Compliance through PAT

GMP Compliance Trends: An Industry Perspective Trend Six: Multiple Compliance Requirements

GMP Compliance Trends: An Industry Perspective Trend Seven: Going Global

GMP Compliance Trends: An Industry Perspective Trend Eight: Going High Tech

GMP Compliance Trends: An Industry Perspective Trend Nine: Risk Management of GMP Inspections

GMP Compliance Trends: An Industry Perspective Trend Ten: Over-committing and under-performing

GMP Compliance Trends: An Industry Perspective Trend Eleven: GMP Compliance to GMP Quality

GMP Compliance Trends: An Industry Perspective Trend Twelve: Risk Taking before Risk Management

GMP Compliance Trends: An Industry Perspective Trend Thirteen: Rx GMPs preferred over Dx GMPs Globalization of Standards Coming together of Regulators and Industry Inspectorate Partnering Control Processes through Validation Skills Competency Validation Resolving Problems