| Compliance > Key Laws, Regulations, Standards, and Guidelines > |
GMP Regulations and Current Preambles
Please click below on the industry for which you would like the GMP regulation, preamble, and any recent Federal Register Notices.
| Blood - 21 CFR Part 606 | Dietary Supplements - 21 CFR Parts 111 and 112 | Medical Device - 21 CFR Part 820 |
| Food - 21 CFR Part 110 | Drug - 21 CFR Parts 210 and 211 | Positron Emission Tomography Drugs - 21 CFR Part 212 |
21 CFR Part 606 -
Current Good Manufacturing Practice For Blood and Blood Components
Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 |
| Recent Federal Register Notices Regarding
Part 606:
Requirements for Human Blood and Blood Components Intended for Transfusion or Further Manufacturing Use: Extension of Comment Period [HTML] [PDF] (11 January 2008) Proposed Rule - Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use [HTML] [PDF] (8 November 2007) Blood and blood components—Current good manufacturing practice; consignees and transfusion recipients notified of increased risk of HCV infection transmission (“lookback”) [HTML] [PDF] (24 August 2007) Direct Final Rule - Biological products: Blood, blood components, and source plasma; requirements [HTML] [PDF] (16 August 2007)
Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment [HTML] [PDF] (24 March 2005) Click here to view older Federal Register notices regarding 21 CFR Part 606. |
21 CFR Part 110 - Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
|
| Recent Federal Register Notices
Regarding Part 110:
There are no recent Federal Register notices regarding part 110. Click here to view older Federal Register Notices regarding 21 CFR Part 110. |
FDA Publishes Final Rule Establishing
Good Manufacturing Practice Regulations for Dietary Supplements [HTML]
[PDF]
(25 June 2007)
|
| Recent Federal Register Notices
Regarding Parts 111:
Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Pra ctice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Extension of Comment Period [HTML] [PDF] (17 September 2007) |
|
21 CFR Part 210 - Current Good Manufacturing Practice In
Manufacturing, Processing, Packing, or Holding of Drugs, General, and
Current Good Manufacturing Practice Regulation and Investigational New Drugs [HTML] [PDF] (17 September 2006) Final Report on Pharmaceutical Manufacturing Initiative Issued (29 September 2004) |
| Recent Federal Register Notices
Regarding Parts 210 and 211:
Federal Register: Direct Final Rule - Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals [TEXT] [PDF] (4 December 2007) Federal Register: Proposed Rule - Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule [TEXT] [PDF] (4 December 2007) Federal Register: Finished pharmaceuticals; manufacturing, quality control, and documentation requirements; withdrawn [TEXT] [PDF] (4 December 2007) Proposed Rule Regarding 21 CFR Part 211: Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reopening of the Comment Period [HTML] [PDF] (30 March 2007) Human and animal drugs: Cattle material; prohibited use in medical products for humans and drugs intended for use in ruminants - proposed rule [HTML] [PDF] (12 January 2007) Current good manufacturing practices— Investigational new drugs; Phase 1 drugs exemption; withdrawn [HTML] [PDF] (2 May 2006) Proposed Rule - Gas containers and closures— Current good manufacturing practice requirements [HTML] [PDF] (10 April 2006) Current good manufacturing practices—Investigational new drugs; Phase 1 drugs exemption Direct Final Rule [HTML] [PDF] (17 January 2006) Change of Name; Technical Amendment [HTML] [PDF] (8 November 2005) Click here to view older Federal Register Notices regarding 21 CFR Parts 210 and 211. |
21 CFR Part 820 - Quality System Regulation
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| Recent Federal Register Notices
Regarding Part 820:
Proposed Rule - Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use [HTML] [PDF] (8 November 2007) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations [HTML] [PDF] (20 September 2007) Medical Devices: Technical Amendments [HTML] [PDF] (9 April 2007) Premarket approval and quality system regulation; technical amendment [HTML] [PDF] (31 March 2006) Click here to view older Federal Register Notices regarding 21 CFR Part 820. |
 Current
Good Manufacturing Practice for Positron Emission Tomography Drugs;
Proposed Rule [TEXT]
[PDF](20
September 2005) |
| Recent Federal Register Notices Regarding
Part 212:
There are no recent Federal Register notices regarding part 212. Click here to view older Federal Register Notices regarding 21 CFR Part 212. |
