What Are GMPs (And Why Are They Important?): Are you a consumer of foods, prescription drugs, dietary supplements, or medical devices?
Since all of us need to eat or take medication or possibly vitamins the answer is yes!
It is satisfying knowing that, as consumers, we can eat food and take prescription medications safely.
Have you ever considered why that is? Well, there is no need to continue wondering.
The reason products are safe for consumption is due to the presence of good manufacturing practices or GMPs.
If you want to know what GMPs are and why they are important, keep reading this article to find out.
What Are GMPs?
GMPs are sets of regulations enforced by the Food and Drug Administration (FDA) to ensure the safety of commercially available products such as foods, prescription drugs, medical devices, and dietary supplements.
You will often see the designation cGMP which stands for current good manufacturing practices.
This is to ensure that manufacturers are staying up to date with their procedures and policies and not relying on outdated information.
To find the regulations manufacturers must follow, you need to look at the Code of Federal Regulations Part 21.
Here you will find regulations of all of the following products the FDA regulates including:
- Drugs – both human and veterinary
- Foods
- Medical Devices
- Biologics
- Cosmetics
- Tobacco Products
Depending on the products your company manufactures will dictate which regulations to follow.
For instance, if your company is a manufacturer of drugs, you would reference 21 CFR 211 for all applicable good manufacturing practices.
Why Are GMPs Important?
It is important for a company to follow good manufacturing practices to ensure that the products they are manufacturing are safe and effective for their intended use.
It is also important for the FDA to regulate these firms to verify they are in compliance with the specified regulations.
GMPs also offer a set standard for all manufacturers to follow.
GMPs cover a range of topics for manufacturers to follow to ensure that their practices are within standards.
In general, the regulations for good manufacturing practices will include areas of manufacturing such as:
- Sanitation and hygiene of workers
- Training and competence of workers
- Validation of procedures, processes, and equipment
- Quality Control of products and processes
- Distribution procedures
- Laboratory functions
- Documentation and record-keeping
If you want to delve more specifically into a certain area of products, such as gmps for dietary supplements or foods, you can look directly at the regulations for the specified products.
Now That You Know The Basics
GMPs are an important and crucial aspect of the manufacture of a variety of products consumers use on a daily basis.
Having a general knowledge of what GMPs are and why they are important will go a long way in helping you understand the role of manufacturers and regulators.
Now that you have been introduced to some basics, read more about GMPs and educate yourself even more on the responsibilities of manufacturers.
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