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