MANUFACTURING PROCESSES AND CONTROLS

1
Figure 6.1
QUALITY SYSTEM
PRODUCTION SYSTEM
FACILITIES EQUIPMENT SYSTEM
PACKAGING LABELING SYSTEM
MATERIALS SYSTEM
LABORATORY CONTROLS SYSTEM
MANUFACTURING PROCESSES AND CONTROLS CGMP
REGULATORY COMPLIANCE
2
Corrections Removals
Medical Device Tracking
Medical Device Reporting
CORRECTIVE PREVENTIVE ACTIONS (CAPA)
FACILITY EQUIPMENT CONTROLS
DESIGN CONTROLS
MANAGEMENT CONTROLS
MATERIALS CONTROLS
PRODUCTION PROCESS CONTROLS
RECORDS/ DOCUMENTS/ CHANGE CONTROLS
Sterilization Process Control
Figure 6.2
3
Figure 6.3
4
DeviceSpecs, design
Animal testing
Pivotal trial
Production prototype
Pilot trial
FDA review
Product concept
Launch
Large scale production
Pilot (low volume) production
50-250 devices
10-50 devices
2-10 Devices per iteration
Design Freeze
FDA inspection
Laboratory Prototypes
GMP manufacturing Recommended needed
Engineers/Technicians
Contractor or in-house
Figure 6.4
5
HIGH
BUY/BUILD Outsource to well established
contractor as collaborator
BUILD
Technical Complexity
BUY/BUILDSelectively contract parts of device
only as needed. Keep assembly and testing in
house.
BUY
LOW
HIGH
LOW
Trade secrets, IP concerns
Figure 6.5