Unique FDA Requirements
The FDA has a long list of strict regulations that benefit the production of nutraceuticals. These regulations have been put into place to ensure that consumers are receiving products that have been accurately labeled, manufactured, and are unaltered.
Prevent Recalls Related to Mislabeling
All Nutraceutical products, which are GMP-certified, must be audited by a Third Party Labeling Auditor using a set of rules concerning labeling restrictions and regulations.
When these rules are not followed, recalls are enforced, especially when mislabeling is involved. In fact, mislabeling has become the number one cause for recalls within the industry.
Foreign Supplies Verification Program - FSVP
Intellect can help enable your organization to effectively comply with FSVP, and other industry standards and regulations. Intellect offers a comprehensive and highly configurable eQMS solution for Nutraceutical, Dietary Supplement and Vitamin organizations.
Food Safety Management Act - FSMA
Nutraceutical, Dietary Supplement and Vitamin companies must use the appropriate documentation that adheres to the standards provided by the Food and Drug Administration’s (FDA) guidelines. Intellect offers a highly flexible software solution for the automation of the design process for all Nutraceutical, Dietary Supplement and Vitamin manufacturers.
Good Manufacturing Practices - GMP
Nutraceutical, Dietary Supplement and Vitamin manufacturers must practice certain regulatory measures, which safeguard their products, making them user safe. ISO 15378:2017 is an international compliance standard that focuses on the packaging materials that are associated with medicinal products. Intellect offers a highly configurable eQMS software solution that makes it easy to comply with all ISO standards for all Nutraceutical, Dietary Supplement and Vitamin manufacturers.
Good Laboratory Practices - GDL
GDL regulations ensure the safety, integrity, and quality of Nutraceutical, Dietary Supplement and Vitamin research laboratories and organizations. ISO 17025:2017 is an international compliance standard that states the general requirements for the competence and consistent operation of testing and calibration laboratories. With Intellect, compliance becomes easy because we offer a highly configurable software solution that makes it easy to satisfy all ISO standards and regulations for all Nutraceutical, Dietary Supplement and Vitamin laboratories.