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Many may question the actual difference between Current Good Manufacturing Process (CGMP) and Good Manufacturing Process (GMP). First, GMP is a set of guidelines created by the Food and Drug Administration (FDA), designed to guarantee that pharmaceutical products are safe, pure, and of excellent quality.
These guidelines ensure that when a company creates and prepares a new product it is done in the cleanest, neatest way possible, ensuring that every container and surface used to make the product adheres to these specific standards. This ensures that everything from record keeping to packaging of that new item is done accurately and precisely and that every employee involved has the appropriate credentials to participate in production.
Both CGMP and GMP are established for product quality assurance. GMP ensures that the product is exactly what the product claims to be and it was manufactured by a set of standard guidelines known as GMP.
However, there are slight differences between cGMP and GMP. cGMP has the “c” to certify that every step used in manufacturing this product was done in accordance with GMP guidelines, but that they were completed in a more current manner. This means that the GMP rules and regulations are constantly improving and increasing to improve the production of new products, the cleanliness and hygiene of the manufacturing process is also being improved and updated.
Another difference between CGMP and GMP is cost. Because cGMP is mostly using new innovative technologies, costs are usually higher than a regular GMP manufacturer. Because new technology is expensive. When compared to GMP products, CGMP products undergo significantly more testing to prove their accuracy than GMP products. It must go through newer, and more in-depth tests and requirements than FDA GMP to ensure certification is accurate and effective.
cGMPs are also put in place to ensure proper use of newly manufactured products. CGMP goes beyond ensuring the quality of new pharmaceuticals that they will be used for what they were created for, it is part of a current standard regulation that is updated frequently so that pharmaceuticals are not so generic. abuse
The term cGMP can be used interchangeably with the term GMP, because when standards are updated and new rules are established, the new ones become current or cGMP. Specifying and certifying that new products are delivered under new standards and regulations as compared to GMP. CGMP regulations are very specific and detailed, using the latest technology available at the time in production. Verifying that every rule prescribed by GMP standards is followed. The overall GMP guidelines do not change they are simply being added so that all pharmaceutical products manufacturers can potentially offer.
