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


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Last updated on 02/10/2016.