Table of Contents |
Chapter
|
Title
|
Page
|
| 1
|
Introduction |
1
|
|
2
|
FDA Quality System Inspection Technique |
2
|
|
3
|
Management Control Requirements
Subpart A - General Provisions
Authority
Quality System
|
4
4
4
4
|
|
|
Subpart B - Quality System Requirements
Management Responsibility
Quality Policy
|
5
5
5
|
|
|
Organization
Management Review
Quality Planning
|
6
6
6
|
|
|
Quality System Procedures
Quality Audit
Personnel
|
7
7
7
|
| 4
|
Management Controls Subsystem Inspection
Pre-Announced Inspections
Getting Started
|
8
8
8
|
|
|
Management Controls Flow Chart
|
9
|
|
|
Management Controls Inspection
|
10
|
| 5
|
Design Control Requirements
General
Design and Development Planning
|
14
14
14
|
|
|
Design Inputs
Design Outputs
Design Review
Design Verification
Design Validation
Design Transfer
|
15
15
15
15
15
15
|
|
|
Design Changes
Design History File
|
16
16
|
| 6
|
Design Controls Subsystem Inspection
Introduction
Design Controls Flow Chart
|
17
17
17
|
|
|
Design Controls Flow Chart |
19
|
| 7
|
Corrective & Preventive Action Requirements |
27
|
| 8
|
CAPA Subsystem Inspection
CAPA Flow Chart
CAPA Inspection
|
28
29
30
|
| 9
|
Production & Process Control Requirements |
38
|
| 10
|
P & PC Subsystem Inspection
P&PC Flow Chart
P&PC Inspection
|
39
39
42
|
| 11
|
Conclusion |
48
|
The QSR Companion