Cosponsored by the Product Quality Research Institute and the Food and Drug Administration

Important Information:

On 21 August 2002 FDA announced a significant initiative entitled cGMPs for the 21^st Century: A Risk Based Approach (http://www.fda.gov/oc/guidance/gmp.html).

This initiative is intended to step back and evaluate the currency of FDA drug product quality regulatory system (CMC review and cGMP inspections) to ensure that:

the most up-to-date concepts of risk management and quality systems approaches are incorporated; the latest scientific advances in pharmaceutical manufacturing and technology are utilized; the submission review program and the inspection program operate in a coordinated and synergistic manner; regulation and manufacturing standards are applied consistently; management of the program encourages and does not impede innovation in the pharmaceutical manufacturing sector; and resources are used most efficiently to address the most significant health risks.

On 20 February 2003 FDA provided information on the progress made on the immediate steps outlined in the 21 August 2002 announcement. This information is available at http://www.fda.gov/opacom/hpnews.html.

This workshop is your opportunity to share with FDA your perspectives and ideas on FDA's current thinking as outlined in the announcement on 20 February 2003 and further explained in presentations at this workshop. This is the inaugural workshop and it is intended to seek your input on certain key elements of the initiative. Information on topics of significant interest not covered in this workshop will be provided and subsequent workshops will be developed for in-depth discussion on these topics.

This workshop utilizes breakout discussion sessions to ensure a very interactive format for you to participate and contribute to the evolution of this initiative. It is therefore important that you review the information provided by FDA on 20 February 2003, available at http://www.fda.gov/opacom/hpnews.html.

Updated Breakout Session Information:

• Changes Without Prior Approval Breakout Session (PDF)
• Integrated CMC Review and Inspection Breakout Session (PDF)
• Manufacturing Science Breakout Session (PDF)
• Risk-Based Breakout Session (PDF)

If you wish to share your perspectives and ideas with FDA and the workshop participants prior to this workshop please submit these in writing to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059. (http://www.fda.gov/ohrms/dockets/dockets/03N0059/03N0059.htm)

Note that the title of this workshop "A Drug Quality System for the 21^st Century" is intended to signify that this is a broad initiative that covers both the cGMP inspection and CMC review processes.

Workshop Objectives and Agenda (PDF)

Presentations of April 22, 2003

• Changes Without Prior Approval An FDA Perspective (PDF)
• Risk-Based cGMPs: Defining Risk and Quality (PDF)
• 21 CFR Part 11 Scope & Application (PDF)
• Benchmarking Semiconductor Manufacturing and its Applicability to Pharmaceutical Manufacturing (PDF)
• Quality Systems and Regulatory Innovation for the 21st Century (PDF)
• Integrating CMC Review and Inspection: A Team Approach (PDF)
• An Investigation into Pharmaceutical Manufacturing Performance and Its Relationship to FDA Oversight and Enforcement Actions (PDF)
• Benchmarking Semiconductor Manufacturing and its Applicability to Pharmaceutical Manufacturing (PDF)
• Manufacturing Science (PDF)
• A Drug Quality System for the 21st Century - Industry Perspective (PDF)
• Changes Without Prior FDA Approval: Demonstrating Product Comparability and Impact on Product Approval and Supply for Protein Therapeutics (PDF)
• Overview of FDA's Drug Quality Initiative and the Workshop (PDF)
• A Perspective on Risk Analysis for the GMP Initiative (PDF)

Breakout Session Summaries of April 24, 2003

• Risk-Based cGMPs: Defining Risk and Quality (PDF)
• Changes without Prior Approval (PDF)
• Integrating CMC Review & Inspection Industry Recommendations (PDF)
• Manufacturing Science (PDF)

April 22-24, 2003
Renaissance Washington DC Hotel