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 needed to remain up to date with the latest technologies, not rely on what was a good practice ten years ago.
cGMPs are followed by pharmaceutical and biotechnology companies to ensure that their items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are 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 regulates electronic records and electronic signatures.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
Importance of cGMP
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances, testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how cGMP requirements help to assure the safety and efficacy of drug products.
If the failure to meet CGMPs results in the distribution of a drug that does not offer the benefit as labeled because, for example, it has too little active ingredient, the company may subsequently recall that product. This protects the public from further harm by removing these drugs from the market. While FDA cannot force a company to recall a drug, companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and can seize the drug.
Code of Federal Regulations (CFR)
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 that are 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.
cGMP and the Pharmaceutical Industry
The CFR’s that relate to cGMP in the pharmaceutical and biotechnology companies are:
- 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General Part (includes the definitions that are used in the regulations such as batch, lot, etc.).
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 600 – Biological Products: General (contains key definitions, establishment standards, establishment inspection requirements and adverse experience reporting requirements).
- 21 CFR Part 11 – Electronic Records; Electronic Signatures (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.)