Current Good Manufacturing Practice (CGMP)
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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]