The Importance of GMP: How a Century-Old Rule Still Keeps Us Safe
You may have noticed a GMP or cGMP stamp on some of your supplement bottles, but what do they mean? GMP (Good Manufacturing Practices) and cGMP (Current Good Manufacturing Practices) are conditions required to manufacture safe products. Any supplement with one of these stamps on it has had their facilities inspected to ensure that their operating and environmental processes are up to federal code. This includes everything from the ingredients that go into the supplements to the location and construction of the buildings.
A Little History on GMP
GMP has been around for a long time—since 1906. The Pure Food and Drug Act of 1906 made it illegal to sell contaminated food and to misbrand tonics and syrups. Throughout the years, the regulations have adapted with new techniques, machinery, and processes used in manufacturing.
Today's Standards
Currently, GMP is regulated by the FDA (Food and Drug Administration). There are five main sections published in the Code of Federal Regulations pertaining to dietary supplements: personnel, buildings and facilities, equipment, production processes and controls, and defects. Each section lists extensive rules that must be followed to ensure that the supplements you receive are clean and safe to consume.
What exactly is required for a manufacturer to qualify for GMP certification?
Here are the basic requirements for a manufacturer to be GMP certified:
- The manufacturing area must be clean and hygienic.
- The manufacturing area is a controlled environment.
- All processes are defined and controlled, and any changes to processes go through careful evaluation.
- Records are made and kept detailing every aspect of each batch.
- There’s a system set in place in case of the need to recall a product.
- All complaints are heard and looked into.
For more about these regulations, see 21 CFR 111.
These rules are enforced by the FDA, and they are checked with every inspection (every 1 to 2 years).
What does this mean for the consumer?
GMP is in place to protect you from unsafe manufacturing practices. Look for a GMP logo on the bottle of any dietary supplement before you decide to purchase. This means that they are safe to consume, and that the ingredients that go into them and the buildings they are made in are safe and sanitary.
At Purely Beneficial, we take great pride in our products and we take your health and safety seriously, so we only use GMP certified manufacturers.