Context:
GMP Certified Supplements
The GMP or cGMP seal ensures that a manufacturer consistently maintains a quality standard and systems to ensure product quality, potency, purity, and identity. Although it does not guarantee the efficacy or potency of the product, it does minimize the risks of any nutritional supplement or food product to health and well-being.
Pharmaceutical companies, health supplement manufacturers, food processors, API manufacturers, or formulators must be GMP certified to sell their products under the law. If any violation of GMP standards is found with the manufacture of the product it is considered "adulterated".
WHO - GMP Certification
GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice' Initiated by WHO in 1968.
First draft for guideline 1969
adopted by the Expert Committee on Biological Standardization (ECBS) in 1991 and establishes the general approach to the quality control of biological medicines that include products such as vaccines, blood and blood products, antigens, cell and tissue therapies, biopharmaceutical products, and others.
More than 100 countries have incorporated GMP defines quality measures for both production and quality control. It is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP or Good Manufacturing Practices
GMPs provide for documented evidence that a manufacturer maintains a level of quality by design and quality systems to ensure product quality, strength, purity, and identity. GMPs require specifications to be established for raw materials, packaging materials, labeling and finished products.
cGMP or Current Good Manufacturing Practices
CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
GMP VS cGMP
The key difference between GMP and cGMP is in their guidelines, rules and regulations. Both GMP and cGMP manufacturing generate high-quality results. But cGMP uses mostly new (current) and innovative technology, which can make it more expensive than regular GMP.
Here are the other notable differences between GMP and cGMP.
Difference Between GMP and cGMP
| GMP | cGMP |
| GMP certification involves the basic guidelines that companies would adhere to, which is why it is more cost effective than cGMP. | cGMP certification is more expensive than GMP because it involves the latest innovative technology. |
| GMP certified products may have lower quality assurance due to the lack of automation and use of technology in the process. | cGMP certified products are more reliable in terms of quality assurance compared to GMP as they are processed through the additional use of innovative technology. |
What Does GMP or cGMP Seal Ensure?
Good Manufacturing Practices (GMP) is a system that ensures that the manufacturing facilities and procedures follow the proper guidelines to produce and control products consistently according to quality standards of products.
- Identity
- Strength
- Quality
- Purity
Importance of the GMP or cGMP Certification for Dietary Supplements
While there is no comprehensive regulatory framework for nutraceuticals and dietary supplements to maintain their safety and standards globally, the GMP seal can help ensure the safety and standard of the health product processing and manufacturing aspect.
It is also significant when purchasing supplements as an over-the-counter health care product, as GMP defines quality measures for both production and quality control.
Please note that GMP certification is not an endorsing claim on the benefits of products, whether they are manufactured by CGMP or GMP certified facilities.
References
https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes
About Author:
Hasan MehediLast update: 2023-01-20 11:12:27
