USA FDA'S 21 CFR PART 820 "QUALITY SYSTEM REGULATION" (cGMPs) COMPLIANCE AUDIT MATRIX
The following are 21 CFR Part 820, Quality System Regulation (cGMP) subparts /
sections (set up for use as an audit checklist):
Subpart Description Reviewed ('Y' or 'N')/Comments
A General:
820.1 Scope
820.3 Definitions
820.5 Quality System
B Quality System Requirements:
820.20 Mgmt. Responsibility
820.22 Quality Audit
820.25 Personnel
C Design Controls - 820.30
D Document Controls - 820.40
E Purchasing Controls - 820.50
F ID and Traceability:
820.60 ID
820.65 Traceability
G Production and Process Control:
820.70 P and PC
820.72 Inspection,
820.75 Process validation
H Acceptance Activities:
820.80 Receiving, in-process, finished device inspection
820.86 Acceptance status
I Nonconforming Product - 820.90
J Corrective and Preventive
Action (CAPA) - 820.100
K Labeling and Packaging Control:
820.120 Device labeling
820.130 Device packaging
L Handling, Storage, Distribution, and Installation:
820.140 Handling
820.150 Storage
820.160 Distribution
820.170 Installation
M Records:
820.180 General requirements
820.181 DMR
820.184 DHR
820.186 QSR
820.198 Complaint files
N Servicing - 820.200
O Statistical Techniques - 820.250
John E. Lincoln, principal consultant, J. E. Lincoln and Associates
LLC
Medical Devices / Pharmaceuticals / Quality / Regulatory Affairs