What does FDA Inspected & cGMP Certified Actually Mean?

The United States Food & Drug Administration (FDA) regulates the quality of pharmaceuticals very very carefully. One of the standards for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMP) regulation. The cGMP ensures that each batch of products will meet quality standards so that consumers know they are both safe and effective. If the manufacturer does not meet these qualification, there is regulatory actions taken against the manufacturer.

 

What is cGMPs?

cGMP, also know as the Current good Manufacturing practice regulations is enforced by the FDA and FDA inspected. and is used by manufacturing facilities to ensure proper quality, purity, design, monitoring, and control of the overall facility. By having this regulation, manufacturers can establish strong quality management throughout their facility and can better detect and investigate any product quality deviations. This helps put a strong quality control practice into place and helps to prevent mix-ups, failures, and errors.

 

Why is cGMPs Important?

The number one answer to this question is the consumer. The consumer is not going to typically know if the supplement or pharmaceutical product is going to be safe unless they are told so. They cannot sense when something is wrong with a product. It is the job of the manufacturer to test and ensure quality. By having a cGMP in place, the manufacturer is responsible for assuring quality. Under this regulation, the entire facility has to be under the conditions set by the cGMP guideline, which ensures that the supplements are manufactured under the proper conditions. This also ensures that quality is built into the design and packaging of the product as well. Overall, the cGMP ensures the consumer that they are getting a quality product.

 

How Does the FDA Regulate cGMPs?

An FDA inspected faculty, such as SDC Nutrition Inc will be regularly inspected by the FDA to ensure they are compiling with the cGMP standards. A highly trained FDA employee will conduct the inspection using an FDA inspection checklist, so that not one facility is favored over another. If a company is found to not be complying with the cGMP standards, then any product that they manufacturer is now considered “adulterated.” If the product is adulterated, this means that it was not manufactured under the conditions of cGMP, not that it is necessarily bad. In rare cases, the FDA will take action and stop the distribution of the faculty. Often, the company is fined and given a period to fix their issues.

 

When is the Public Notified About cGMP violations?

The FDA often releases reports to the public that warns consumers that the drugs could serious implications for their health. If necessary, the FDA will issue a public recall of the product so that they can remove the harmful drugs from the marketplace and let consumers who already bought the product know to discontinue using it. The FDA also publishes regulations and guidance documents for the entire pharmaceutical and nutraceutical industry in the “Federal Registrar” this allows the public to see just exactly what the FDA is doing and why they are doing it.

 

Is cGMP Required for Manufacturers?

Yes. If you are in the supplement industry, you need to comply with cGMP regulations. This is an FDA regulated industry, so your faculty and production will need to be up to code at all times. The FDA website features guidance documents online that can help your facility stay on track and answer any questions that you may have concerning the regulation.