Download 2:15PM - Metric, Data and Analysis, and Biometrics

Metric, Data and Analysis
Biometrics
Ricki A. Chase
Director, Investigations Branch
[email protected]
312-596-4240
• Center Work Planning
• District Work Planning
• Factors Driving Frequency
• Unplanned Work
• Data
• What’s New
Center Work Planning (CDER)
– Process and Communication between CDER
and ORA
– CDERs Risk Model
– Assignments to the field
• Focus on change management
• Compounding Pharmacies
Factors of CDER’s Risk Model (Top Level)
– Product
• Dosage Form
• Intrinsic Chemical Properties
– Facility
• Poor GMP Compliance History
– Process
• Measuring
• Mixing
• Compression
• Filling
Top Ranked High Risk Product Categories
– Biotech
– Liquid Sterile Solution
– Liquid Sterile Suspension/Emulsion
– MDI low active
– MDI high active
Poor Compliance History
• Recalls
• FARs
• Warning Letters/Recidivist
• Under Consent Decree
• Failure to obtain application
Process Factors
• Contamination
• Yield
• Changeover
• Cleanability
• Validation
• Maintenance
District Work Plan (CDER)
Center Work Planning (CDRH)
– District Driven Process
– Special Coverage Requests to the Field
•Data driven directed inspections
CDRH Special Factors
• Class 1 Inspection Initiative
– Increase number of recalls
– Inconsistencies in device registration/listing
– Better use of resources
District Decision Factors
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Statutory Requirement to Inspect
Classification of Device
Compliance History
MDRs and Recalls
Industry Trends
Unplanned Work
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Recalls
6 months post regulatory action
FARs/MDRs
Directed Inspection Request
Pre-approvals
Consumer Complaints
Recalls
Recall Activities
Pharma Observation Trends
• QCU
• Production/Process
Control – not followed
• Lab Controls
• Batch Discrepancies
• No P/PC
• 21 CFR 211.22(d)
• 21 CFR 211.100(b)
• 21 CFR 211.160(b)
• 21 CFR 211.192
• 21 CFR 211.100(a)
Pharma Inspectional Specifics
2013
• 537 Total Inspections Classified OAI
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–
–
–
–
81
69
20
6
5
56002 – Drug Manufacturing
56002A – Sterile Drugs
56002F – API
56002H – Abbreviated Drug EI
56002B – Drug Repackers/Relabelers
Device Observation Trends
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CAPA Procedures
MDR Procedures
CAPA Activities
Process Validation
Complaint Handling
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21 CFR 820.100(a)
21 CFR 803.17
21 CFR 820.100(b)
21 CFR 820.75(a)
21 CFR 820.198(a)
Device Inspectional Specifics
2013
• 537 Total Inspections Classified OAI
–
–
–
–
–
–
–
131
30
29
25
22
145
25
82845B – Full QSIT
82845C – Compliance Inspection
82845A – Abbreviated QSIT
82845G – For Cause
82845S – Sterile Device
81001 – MDR
81845R – Corrections/Removals
Enforcement Trends
What’s New?