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What it Means to be a cGMP Supplement Manufacturer

by | Jul 26, 2017 | Diet Pills | 0 comments

There are thousands of dietary supplements currently available for Americans to purchase and hundreds of those include diet pills. That said, their qualities vary widely. Yes, their formulas play an important role, but so do the way in which they have been manufactured. You may have noticed that some brands claim that their products are produced by a cGMP supplement manufacturer, but what does this really mean?

Does a diet pill made by a cGMP supplement manufacturer have FDA approval? Does this mean that it’s known to work as it claims or that it is safe to use? Does it mean that the product’s manufacturer has undergone inspections to make sure they’re clean and that they have the right practices in place to ensure that the products are created with the precision needed to reflect what is on their labels?

To start, it’s important to understand what the term cGMP supplement manufacturer actually stands for. The “cGMP” acronym stands for “current good manufacturing practice.”

In the U.S., the Food and Drug Administration (FDA) regulates human pharmaceutical quality. The cGMP is the FDA’s regulatory guideline. It is designed to make sure that pharmaceutical manufacturers will consistently meat quality standards in every batch of product, ensuring that they will be safe and effective.

The FDA enforces the cGMP regulations to be sure that facilities claiming to have been inspected and approved are properly designed, monitored and controlled throughout the building, its equipment and its production methods.

That being the case, this doesn’t mean that a supplement manufacturer adhering to cGMP guidelines can say that the FDA has approved its product. That is not the nature of the designation. However, when a manufacturer adheres to the regulations, it means that the drug or supplement they are producing will be properly identified and will have a consistent and accurate strength, purity and quality. The FDA is quite strict about the way in which a facility must function throughout the manufacturing process in order to receive the agency’s approval.

The official FDA website is careful to point out that the reason is that the “C” in the cGMP designation requires a facility to remain current with all the latest regulations, systems and technologies. After all, tech and systems meant for accuracy and contamination prevention a decade or two ago are hardly up to the capabilities of today’s equipment. That said, the terms cGMP and GMP are often used interchangeably.

The FDA determines whether or not a facility is cGMP regulation compliant by conducting inspections. The agency sends its own highly trained staff members and will also take public reports of potentially defective products into account. Using the cGMP label without the FDA’s permission is illegal.

source: https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htm

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