Difference between cGMP and GMP : Pharmaguideline

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Difference between cGMP and GMP

cGMP is the advance version of the GMP because cGMP states for current GMP guidelines those are updated periodically by the pharmaceutical regulatory agencies for GMP inspection.
Many people may question the real difference between current Good Manufacturing Process (cGMP) and Good Manufacturing Process (GMP). First off GMP is a set of guidelines, created by the Food and Drug Administration (FDA), that the pharmaceutical industry has put into place to guarantee the products are safe, pure and of great quality.

These guidelines are in place to be sure that when a company is manufacturing and preparing new goods it is done in the cleanest, neatest way possible, ensuring every utensil and surface used to create the product was up to these certain set of standards. It also certifies that the process from record keeping, all the way to the packaging of that new good, is done correctly and precisely, and every employee involved had the proper credentials to partake in the production.

GMP-vs-cGMPBoth cGMP and GMP are put into place to certify quality assurance of products. GMP ensures that the product is exactly what the product claims to be and that it was created by the standard guideline set known as GMP.

However, there is a little difference between cGMP and GMP. The "c" in cGMP is in place to certify that every step used in producing this product was done as the guidelines of GMP are stated, but they were finished in a more current manner. This means that as GMP rules and regulations are constantly improving, and increasing to better the production of new goods, the cleanliness of the process of creation, and neatness are also being improved and updated.

Another difference between cGMP and GMP is the cost. Since cGMP is mostly using new innovative technology the cost is usually more to implement than a regular GMP manufacturer. This is because new technology is expensive. When compared to the GMP goods, cGMP goods undergo remarkably more testing to prove the accuracy of it, compared to that of GMP. It has to undergo newer, and more in-depth testing and requirements than that of FDA GMP so that the certification is accurate and proven to be effective.

cGMP is also put into place to watch for the proper use of the new manufactured goods. cGMP goes above and beyond to ensure that the quality of the new pharmaceutical, and the assurance that it will be used for what it was created for, this is part of a current standard regulation that is updated frequently so that pharmaceuticals are not being so commonly misused.

The term cGMP may be interchangeable with the term GMP, that is because when standards are updated and new regulations are put into place, the new ones become the current, or cGMP. Stating and certifying that the new goods were distributed under newer standards and regulations than those of the GMP. cGMP regulations are very specific and detailed, using the newest technologies available at that time in production. Verifying that every regulation was followed that was set by the standards of GMP. Overall GMP guidelines do not change they are just being added to so that all pharmaceutical products are the best the manufacturers can possibly offer.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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  1. Best information sir , thanks

  2. Excellent portal for Pharma information.


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