At Peak Nutritional Products, we pride ourselves on our high manufacturing standards. Our multitude of credentials prove our dedication to quality: We’re Certified Organic by Oregon Tilth and follow cGMP manufacturing standards established by the Food and Drug Administration. Let us explain what these titles mean.
According to their website, Oregon Tilth is a leading nonprofit organic certifier in the United States. To give some insight into the certification process, here’s how it happens:
- The applicant writes an Organic System Plan personalized to their situation. They provide details, such as operation type and location, which form the basis for points of inspection. With the OSP, Oregon Tilth will test multiple facets of the operation for compliance with regulations.
- Oregon Tilth does an initial review of the plan.
- If the plan passes, a trained inspector conducts an on-site inspection.
- Oregon Tilth reviews the finalized application.
- Then, they reach a resolution.
- Oregon Tilth rewards operations that meet their standards with a certificate, which needs to be updated annually.
As for what cGMP stands for, it means “Current Good Manufacturing Process,” according to the FDA’s website. This standard is created by the FDA to regulate pharmaceutical quality, so facilities maintain strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect and investigate product quality deviations, and maintain reliable testing laboratories.
If a drug is distributed without following cGMPs, (i.e., if the active ingredient content is too low) the FDA can request a recall. If the company refuses to recall, the FDA can warn the public and seize the drug. cGMP is only the minimum requirement, however, and at Peak Nutritional Products, we seek to rise beyond expectations. We only use the highest quality raw materials and submit every product to an independent testing lab. With these quality assurance standards, we hope that our customers will have confidence in every product we manufacture.