Creative Ideas for Teaching GMP
By Madison Area Technical College Biotechnology Department
Back To GMP Table of Contents
Authors: Noreen Warren and Lisa A. Seidman, Ph.D.
Address: Madison Area Technical College
3550 Anderson St. Madison, WI 53704
July 18, 2000
This page explains how to use the internet to obtain thecurrent Good Manufacturing Practices (cGMP) regulations. It describes how the regulations are organized and how they can be searched and retrieved.
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules of the federal government1. The CFR contains the complete and official text of the regulations that are enforced by federal agencies.
The CFR is organized as follows:
The CFR is divided into 50 titles that represent broad areas subject to Federal regulations.
Each title is divided into chapters that are assigned to various agencies issuing regulations pertaining to that broad subject area.
Each chapter is divided into parts covering specific regulatory areas.
Large parts may be subdivided into subparts.
Each part or subpart is then divided into sections -- the basic unit of the CFR.
Sometimes sections are subdivided further into paragraphs or subsections. Citations pertaining to specific information in the CFR will usually be provided at the section level.
An example of a typical CFR citation is 21 CFR 211.67(a). Here is what this citation actually means:
The number 211 is the part. Part 211 is entitled "Current Good Manufacturing Practice for Finished Pharmaceuticals".
The number .67 refers to a particular section. This section is about AEquipment Cleaning and Maintenance.@
The (a) is the first paragraph or subsection within the section.
There are several ways to access the portions of the CFR relating to the manufacture of pharmaceuticals using the web 4 :
The FDA web site includes a copy of 21 CFR parts 210 and 211. The entire CFR dealing with cGMP is located here.
The FDA web site, includes along with the federal regulations, notes, proposed changes in the regulations and other pertinent information concerning cGMP. This site provides easy access to an up-to-date copy of the cGMP regulations along with explanatory information. The "Notes" portion is a collection of memos for FDA personnel on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals.
The Government Printing Office maintains a searchable site if you want to retrieve any CFR. To search this site, fill in blanks with the title number, the part number, and the section number. The computer will then retrieve that section.
Another site that publishes some of the FDA regulations is a commercial site hosted by The GMP Institute. This site includes the following useful items:
Footnotes:the National Archives and Records Administration web site. This government web site explains what the Federal Register is and provides access to government documents. titles of the CFR is assigned to a specific agency. The Government agencies that have regulatory control can be determined by the relevant CFR Titles, Subchapters or Chapters.
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