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Current Good Manufacturing Practice (cGMP) and How to Use Them
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Current Good Manufacturing Practice (cGMP) and How to Use Them
Pharmaceutical Quality affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals. Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (cGMP) regulations.
The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and the product has been checked for quality more than just at the end phase. 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 good practice 10 years ago. GMP is typically ensured through the effective use of a quality management system (QMS).
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.
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.
What are the difference between GMP and cGMP?
GMP is Good Manufacturing Practice Regulations given by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. GMP is sometimes referred to as “cGMP”. “c” stands for “current,” reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. “c” should be written in small letters as it is dynamic and it changes.
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.
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