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What are GMP Guidelines and Regulation?

Some acronyms exist in the manufacturing sphere that are intuitive and easy to follow. GMP is one of those. More particularly, GMP is an extremely important acronym to know. GMP guidelines and regulations are key concepts that are ubiquitous in several spheres.

We shall go into details shortly. But first, let’s start with the question, “what is GMP?”

 

What is GMP?

GMP is short for Good Manufacturing Practice. It was enacted out of the concern that arose when companies produced health-related products that were sub-standard, and thus, posed as a threat to human health. In this post, we’ll go through what GMP Guidelines and Regulation is all about.

 

Good manufacturing practices (GMP) are a set guideline laid out by recognized agencies. These guidelines are designed to ensure that food products, cosmetics, beverages, pills, and medicinal products meet up to a level of high quality. The regulation covers a wide range of operations, from manufacturing to the control of the facility, to processing, to packaging and to distribution.

In recent times, the acronym “cGMP” is commonly used. It stands for Current Good Manufacturing Practices. Since older GMPs are outdated, the new nomenclature helps to remind companies to make use of the updated systems, technologies and operations. This will help to reduce the reduce the risk of error and impurity that are associated with older manufacturing practices.

Several GPMs are adopted all over the world. The two most popular ones are WHO GPM and FDA CGMP.

 

World Health Organization (WHO) GMP

In 1969, the World Health Organization (WHO) recommended the first version of GMP in order the ensure the quality of pharmaceutical products around the globe. In 1991, it was extended to take account of the quality of biological medicines like blood, cell and tissue, antigens and so on, under the Expert Committee on Biological Standardization (ECBS).

The World Health Organization GMP is the most adopted practice in the world. Over 100 countries have incorporated it into their national medicine laws, primarily countries in developing countries.

 

Why do we need GMP?

Here’s an analogy that will greatly improve your understanding of the need for GMP.

Any time you are sick, you take a pill. Just by mere sight, can you tell if it is going to work? Definitely not! Similarly, you cannot differentiate if it is a placebo or effective. You cannot even tell if it is spoilt or if it will have a detrimental effect on your health. However, we use them and trust in their efficacy because we know that those pills must have been held accountable by regulatory agencies to produce pills in line with good manufacturing practices.

Similarly, surgeons have no way of telling if their equipment is sterile just by looking at it. However, because of GPM compliance, they can be guaranteed of the sterility of their tools. The same logic holds true for the food we consume and the cosmetics we make use of.

If GMP were to be rescinded, end users will be exposed to larger health risks because the quality of products will drastically fall – because corporations, by default, are motivated by higher profit. Most of them will manufacture products with the cheapest approach, regardless of health risk. Therefore, the presence of GMPs is highly indispensable.

 

The 10 Golden Rules of GMP

There are 10 general golden rules that encompass how to keep a good manufacturing practice. To find more about them, check out our post on 10 Tips on How to Keep a Good Manufacturing Practice.

 

Compliance and Enforcement

Several countries have different regulatory bodies that create and enforces good manufacturing practices in companies. To have a glimpse of who they are and how they operate, you can view our post on The Ultimate Guide to Introduction to GMP, under the subheadings: variation of GPM and Enforcement.

When companies defy GMP guidelines, regulatory bodies will warn the public about the dangers of using such products. In addition, regulatory bodies have the right to take legal action against erring companies. An Injunction case can be made against such a company. This can be in the form of an order to stop the production and distribution of substandard products or an order to make the necessary correction in the facility so as to raise the standard of the product to safe levels.

 

Learning More About GPM

If you’re starting a food or drug company, the knowledge of good manufacturing practices is a must. This knowledge is important so that you can manufacture products that are safe to consume or use and also, to avoid sanctions from regulatory bodies.

Furthermore, regulatory bodies usually notify the public about safe practices through their websites. Links to CGPM regulations, guidance documents and other resources are available to assist companies to obey the accepted practices.

Conclusion

The importance of GMP cannot be overemphasized. If you own an establishment and you fail to follow good manufacturing practices, this might spell doom for your business. If you want to know how we can help you with GMP compliance, sign up now and try Prodsmart for free.

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