Current Good Manufacturing Practice (cGMP) Regulations
In the United States, Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration's (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. The word "current" was added to signal to companies that they need to remain up to date with the latest technology rather than rely on what was a good practice 10 years ago.
Pharmaceutical and biotechnology companies follow cGMPs to ensure their items are manufactured to specific requirements including identity, strength, quality, and purity. Compliance is regulated by the Food and Drug Administration (FDA).
There are a number of federal regulations that relate to cGMP which, if not followed, can lead to criminal penalties. There are two specific regulations that relate to pharmaceutical manufacturers, one for biological products, and a regulation that monitors electronic records, counterparts, and electronic signatures.
In an excess of caution, some companies have opted to adopt practices, procedures, and risk management systems that go above and beyond cGMP regulations.
Code of Federal Regulations' Role in cGMP Regulations
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules of the federal government. The CFR contains the complete and official text of the regulations that are enforced by federal agencies.
The CFR is divided into 50 titles that represent broad areas subject to federal regulations. Each title is divided into chapters assigned to various agencies issuing regulations pertaining to that broad subject area.
Each chapter is divided into parts covering specific regulatory areas. Each part or subpart is then divided into sections—the basic unit of the CFR. Sections are sometimes subdivided further into paragraphs or subsections. Citations pertaining to specific information in the CFR usually will be provided at the section level.
The Pharmaceutical Industry's cGMP Regulations
The CFRs that relate to cGMP in the pharmaceutical and biotechnology companies are:
- 21 CFR Part 210: Processing, Packing, or Holding of Drugs: In general, this governs cGMP for the manufacturing, processing, packaging, or holding of drugs. Part 210 includes the definitions that are used for terms in the regulations such as batch, lot, etc.
- 21 CFR Part 211: Finished Pharmaceuticals: This is for finished pharmaceuticals. For example, a liquid medication leaching through a plastic container would be covered by Part 210, but a pill breaking apart after it ships likely would be covered by Part 211.
- 21 CFR Part 600: Biological Products: This is related to biological products and contains key definitions, establishment standards, property inspection requirements, and adverse experience reporting requirements.
- 21 CFR Part 11: Electronic Records and Signatures: This contains the guidelines on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records. Part 11 also applies to submissions made to the FDA in electronic format.
The FDA's Role in cGMP Regulations
According to the FDA, one of the reasons drug manufacturing is regulated so strictly is to ensure uniformity across all products. A drug manufacturer may produce millions of pills, but only a fraction of a percent of them will be tested because doing so destroys them.
For this reason, it is important that all pills be manufactured under the same conditions and according to the same guidelines so consumers can be confident the pills being sold are identical to the pills being tested.