GMP and cGMP are two common terms in pharmaceutical manufacturing. In this article we try to find out the differences between GMP and cGMP in pharma industry.
- GMP requires manufacturers to ensure that their products are safe and effective.
- cGMP requires manufactures to employ technologies and systems that are up to date and comply with GMP regulations.
- GMP stands for Good Manufacturing Practices which require manufacturers, processors, and packages of drugs, medical devices, certain food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
- cGMP stands for Current Good Manufacturing Practices. Manufacturers who follow cGMPs must employ technologies and systems which are up to date that also comply with GMP regulations.
- GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. These regulations are enforced by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.
- cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls. This flexibility allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.
- Cost is also a notable differentiator. cGMP uses new, innovative technology, which can be more expensive. cGMP goods undergo significantly more testing to ensure proper use of new manufactured goods and that certification is accurate and proven to be effective.
“c” in cGMP
“c” in cGMP stands for current, requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been “top-of-the-line” to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.
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Resource Person: Barbara Pirola