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 these products must fulfil 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.
Key Takeaways
- cGMP stands for “current Good Manufacturing Practice,” which refers to the latest pharmaceutical and medical device regulations.
- GMP, or “Good Manufacturing Practice,” is a more general term for guidelines that ensure quality and safety in production.
- Both cGMP and GMP aim to protect consumers, but cGMP emphasizes staying current with evolving industry standards.
cGMP vs GMP
cGMP (Current Good Manufacturing Practices) places more emphasis on documentation, record-keeping, and validation of manufacturing processes, and is enforced by the US Food and Drug Administration (FDA). GMP (Good Manufacturing Practices) are enforced by national regulatory bodies.
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, which deals with 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
| 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: Current Good Manufacturing Product.
The Food and Drugs Administration Authority (FDA) department of the United States of America introduced the quality program.
The department behind introducing the standard aimed to control and ensure the companies’ designing, monitoring, and manufacturing process.
The best way to enter the market of different companies is to stick to the standards introduced that include a strong infrastructure, acquiring early standard measures, an operating system that is fully functional or advanced technology, etc.
This is done so because to reduce the chances of contamination and errors.
The quality assurance is well maintained, and the field area of regulations in the case of cGMP is limited 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 Food and Drug Administration Authority of the United States of America introduced the given quality standard.
The standard was introduced to complement the Food, Drug, and Cosmetic Act regulations.
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 that is dangerous to consume, apply, or use. So to avoid the same quality is to be 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 losses 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 look into all the manufacturing processes used by different companies, while comparatively, on the other hand, applying 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 the United States of America is used by over 100+ countries worldwide.
- 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.
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
Last Updated : 24 June, 2023
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Piyush Yadav has spent the past 25 years working as a physicist in the local community. He is a physicist passionate about making science more accessible to our readers. He holds a BSc in Natural Sciences and Post Graduate Diploma in Environmental Science. You can read more about him on his bio page.
An article with excellent detail on the cGMP vs. GMP, and the importance of the current good manufacturing practices.
Thanks for providing such detailed information. It’s important for companies to understand these standards to ensure product quality is maintained.
Absolutely, the quality and safety aspects of production are critical for consumer protection.
The comparison table clearly illustrates the differences between cGMP and GMP, providing a comprehensive view of their characteristics.
Indeed, the differences in cost, applications, and quality levels are well articulated, making it easier to understand.
The discussion on quality assurance and acquisition of guidelines for cGMP and GMP standards adds depth to the article’s content.
This is an informative piece shedding light on the intricacies of cGMP and GMP, making it easier for readers to comprehend these standards.
This article precisely highlights the differences between cGMP and GMP, emphasizing the importance of compliance with these regulations for companies.
A well-structured article delineating the key differences between cGMP and GMP, conveying the importance of adhering to quality standards.
Absolutely, the relevance of these standards cannot be understated, and the article covers the subject comprehensively.