PAT UPDATE RAPID MICROBIOLOGY

1
PAT UPDATERAPID MICROBIOLOGY

• Bryan S. Riley, Ph.D.
• Review Microbiologist
• CDER/OPS
• Advisory Committee for
• Pharmaceutical Science
• April 13, 2004

2
Rapid Microbiology and PAT

• ACPS - PAT Subcommittee Meeting October 23, 2002
• Rapid Microbiology Breakout Session

3
Rapid MicrobiologyTraining

• July 2003 - Rockville, MD
• CDER, ORA, CBER and CVM
• Agenda
• Overview of RMM Technologies
• Two RMM Vendors
• RMM Validation Experience

4
Rapid Microbiology Team

• PAT RMM Team Members
• Bob Coleman, ORA/DFI (Team Leader)
• Dennis Guilfoyle, ORA/NERL
• Brenda Uratani, CDER/OC
• Bryan Riley, CDER/OPS

5
Rapid Microbiology Submissions

• Pre-Submission Meeting with Applicant
• Comparability Protocols
• Product Release Testing
• Water Testing
• CBE-0 (Implementation)
• Product Release Testing

6
Rapid MicrobiologyInspection

• RMM Team Meetings
• Sept 2003
• Feb 2004
• Inspection (Feb 2004)

7
Future of Rapid Microbiology

• Traditional Microbiology Methods
• Days (Weeks)
• Current RMM Technology
• Days or Hours
• Future of RMM
• In-Line, Real-Time Testing?