《2016-01-PDA-West-Coast》.ppt

Agenda 1. History 2. Compliance Tool 3. Preamble 4. Key Points 5. System Design 6. Personnel 7. Process Simulation Studies 8. Survey History of Guidance Document Previous Document, 1987 Early Draft Public, 1997 PDA Points to Consider, 8/00 - 2/02 PQRI, 3/03 FDA Draft Guidance, 8/03 PDA Comment, 11/03 FDA Final Guidance Document, 9/04 PDA Input Received by FDA PDA’s Points to Consider 37 are aligned 5 are partially aligned 1 not aligned 6 are not addressed All PQRI Recommendations were Adopted PDA made 100 Comments 39 were adopted 19 alternates were adopted 52 were rejected Other Public Comments 61 parties submitted comments to the docket Over 1800 individual comments recommended text modifications many introductory comments from industry and organizations lauded guidance as flexible and science-based, and commended FDA’s openness to public input guidance still needed further improvements several technical issues had comments on both sides of matter Aseptic Processing Workgroup Members Susan Bruederle, ORA Robert Coleman, ORA Kris Evans, CDER/OC Rick Friedman, CDER/OC Joe Kutza, CDER/OPS Bob Sausville, CBER/OC Marla Stevens-Riley, CDER/OPS Paul Stinavage, CDER/OPS* Brenda Uratani, CDER/OC *no longer with FDA Agenda 1. History 2. Compliance Tool 3. Preamble 4. Key Points 5. System Design 6. Personnel 7. Process Simulation Studies 8. Survey Compliance Tool Demo PDA developed a software based compliance tool for its members Compliance tool can be obtained at: /2004%20Aseptic%20Processing%20Forum%20Compliance%20Tool/ Purpose of Compliance Tool Review guidance document and identify best practices gaps that need to be addressed current practices that are overkill Develop Compliance Plan Training Inspection readiness Agenda 1. History 2. Compliance Tool 3. Preamble 4. Key Points 5. System Design 6. Personnel 7. Process Simulation Studies 8. Survey Pre-Amble FDAs guidance documents do not establish legally enforceable responsibilities. Gui