Different countries are famous for manufacturing some specific products that may be anything like – food items, auto parts, electronics, gadgets, handicrafts, etc. to maintain the quality of these products there should be a certain parameter that must be fulfilled by these products before distribution in the market. Thus in the United States of America, there is an organization or department called the Food and Drug Administration that has created different parameters to ensure the quality of the products. The parameters include cGMP and GMP despite being believed to be the same by customers they are different from each other.
cGMP vs GMP
The main difference between cGMP and GMP is that cGMP is known to be the updated regulations by the pharmaceutical companies that ensure the safety standards and goes for the inspection while comparatively, on the other hand, GMP is defined to be the standard which is acclaimed by a product as said by the specific company.
cGMP is also known as the ‘Current Good Practicing Products’. The standard has been created by the Foods and Drug Administration department of the United States of America that deals in the monitoring, ensuring, and manufacturing processes. The products have to be clear of the high-quality standards of identity and purity.
GMP is also known as the ‘Good Practicing Products’ and this quality standard was also created by the Foods and Drug Administration department of the United States of America. The standard deals with food items, drugs, and medical devices. The different companies have to fulfill all the assigned norms and regulations completely to be passed failing to do so will lead to being stamped ‘adulterated’ and will be rejected.
Comparison Table Between cGMP and GMP
| Parameters of Comparison | cGMP | GMP |
| Cost | Expensive to be maintained | Less expensive to be maintained |
| Applications | Deals mainly with the manufacturing standards | Deals with in-depth different procedures like – purity, label marking, complaints, etc |
| Usage | Used by a smaller number of countries | Around 100+ countries are using it |
| Quality Assurance | Utmost quality is checked | Quality level checking is low |
| Acquisition | Less acquirable | More acquirable |
What is cGMP?
cGMP is the term associated with a quality standard norm which is as follows – Current Good Manufacturing Product. The quality program was introduced by the Food and Drugs Administration Authority (FDA) department of the United States of America. The department behind introducing the standard aimed to control and ensure the designing, monitoring, and manufacturing process of the companies.
The best way to enter the market by different companies is to stick to the standards introduced that include the strong infrastructure, acquiring early standard measures, the operating system that is a fully functional or advanced technology, etc. This is done so because to reduce the chances of contaminations and errors.
The quality assurance is well maintained and the field area of regulations in the case cGMP is limited up to manufacturing units. Although the basic aim is to upgrade different eligible companies towards using advanced technologies.
What is GMP?
GMP is the term used for a quality standard and is as follows – Good Manufacturing Product. The given quality standard has been introduced by the Food and Drug Administration Authority of the United States of America. The standard was introduced to complement the regulations under the Food, Drug, and Cosmetic Act.
The main area of interest is to regulate the standards of companies manufacturing food items, drugs, medical equipment, cosmetics, etc. This is so because the items can be mixed with some harmful chemical or food item which is dangerous to consume or apply or use. So to avoid the same quality is to assured at every step.
When the product is failed in any of the tests the complete manufactured product batch or lot number is labeled as ‘adulterated’ and is rejected leading to huge loss sometimes. These standards are followed by approximately 100+ countries worldwide.
Main Differences Between cGMP and GMP
- The cost required in the cGMP standard is expensive as the company needs to buy new advanced technology required for the manufacturing process while comparatively, on the other hand, the cost required in the GMP standard is cheap as it basically deals with the after the process.
- The application of the cGMP standard is to have a look into all the manufacturing processes used by different companies while comparatively, on the other hand, the application of the GMP standard is to achieve all the necessary rules and norms with utmost sincerity.
- cGMP standard prescribed by Food and Administration Authority is not used by many countries while comparatively, on the other hand, the GMP standard also prescribed by the FDA department of United States of America is used by over 100+ countries around the world.
- The quality assurance level of any product manufactured under the regulations of the cGMP standard is very high while comparatively, on the other hand, the quality level of assurance in the case of the GMP standard is low.
- The acquisition of guidelines of cGMP standards is limited to a certain field of regulations while comparatively, on the other hand, the acquisition of guidelines regulated under GMP standards belongs to a vast area of the field and thus is more acquirable.
Conclusion
To summarize the given topic this can be concluded that with every day new products launching the quality standard of the product must be ensured sincerely. These standards will help to keep a check on the manufacturing process, maintain safety standards while production, ensuring complete monitoring. Purity and quality are the two key standards that should be fulfilled by all pharmaceutical companies, food items companies, beverages, medicine equipment, and many others.
For all the above purposes United States of America designed a governing body named ‘Food and Drugs Administration Department (FDA). They have proposed certain regulatory norms that are needed to be fulfilled before launching or delivering any product in the market. Every batch manufactured must be quality approved on the standards issued by the department. And if any batch or product lot is failed to do so the complete batch of the company is being rejected and they face a huge loss.
References
- https://www.nature.com/articles/317061a0
- https://www.pnas.org/content/88/4/1197.short
- https://www.nature.com/articles/308452a0
- https://www.sciencedirect.com/science/article/abs/pii/S0197018604000658