Current Good Manufacturing Practice (CGMP)


Title 21--Food And Drugs
Chapter I--Food And Drug Administration
Department Of Health And Human Services
Part 820--Quality System Regulation

This section provides the text of Title 21, Volume 8, Part 820 of the Code of Federal Regulations (as revised April 1, 2003). Regulation 21CFR820 represents the US Food and Drug Administration's requirements for good configuration management practices. Our intent is simply to provide insight into accepted configuration management principles in a regulatory environment. While this text is believed to be an accurate transcription of the regulation, if your company is subject to FDA regulation you should obtain the current regulation directly from the Food and Drug Administration.

21 CFR Part 820: Contents

Subpart A General Provisions
Sec. 820.1 Scope.
Sec. 820.3 Definitions.
Sec. 820.5 Quality system.
Subpart B Quality System Requirements
Sec. 820.20 Management responsibility.
Sec. 820.22 Quality audit.
Sec. 820.25 Personnel.
Subpart C Design Controls
Sec. 820.30 Design controls.
Subpart D Document Controls
Sec. 820.40 Document controls.
Subpart E Purchasing Controls
Sec. 820.50 Purchasing controls.
Subpart F Identification and Traceability
Sec. 820.60 Identification and Traceability.
Sec. 820.65 Traceability.
Subpart G Production and Process Controls
Sec. 820.70 Production and process controls.
Sec. 820.72 Inspection, measuring, and test equipment.
Sec. 820.75 Process validation.
Subpart H Acceptance Activities
Sec. 820.80 Receiving, in-process, and finished device acceptance.
Sec. 820.86 Acceptance status.
Subpart I Nonconforming Product
Sec. 820.90 Nonconforming product.
Subpart J Corrective and Preventive Action
Sec. 820.100 Corrective and preventive action.
Subpart K Labeling and Packaging Control
Sec. 820.120 Device labeling.
Sec. 820.130 Device packaging.
Subpart L Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling.
Sec. 820.150 Storage.
Sec. 820.160 Distribution.
Sec. 820.170 Installation
Subpart M Records
Sec. 820.180 General requirements.
Sec. 820.181 Device master record.
Sec. 820.184 Device history record.
Sec. 820.186 Quality system record.
Sec. 820.198 Complaint files.
Subpart N Servicing
Sec. 820.200 Servicing.
Subpart O Statistical Techniques
Sec. 820.250 Statistical techniques.

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2003]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR820]