NutriCompliance provides advisory services that guide manufacturers of nutritional supplements on how to meet cGMP standards. Those services include procedures for production and processing such as:

• Meeting requirements for labels and packaging
• Maintaining quality control
• Developing Records and recordkeeping
• Recording information on returned dietary supplements
• Tracking product complaints

The cGMP rules are designed so that nutritional supplements meet quality standards. Manufacturers and handlers of supplements must establish and implement controls to maintain product identity, purity, strength and composition of their products. Those controls apply from the first step of manufacturing through the shelf life of the finished product.

According cGMP rules, manufacturing equipment must be designed, constructed, operated and maintained in a way that conforms to its intended use. Processing, blending and testing equipment must be suitable for use, correctly installed, cleaned and calibrated regularly. Raw materials must be safe and tested to confirm identity. Specifications and quality control procedures for in-process materials and finished products must be established, followed and documented. Plant personnel must be properly trained and adhere to basic standards of hygiene.

Firms that distribute dietary supplements under their own labels are fully responsible for ensuring their products comply with cGMP requirements throughout the entire product life cycle, regardless of whether or not they manufacture the products in their own facilities. Companies hire third parties to make their products must monitor those companies to make certain that they comply with the rules. Part of that requirement is that the manufacturers keep accurate batch records for every lot.

Likewise, procedures must be implemented for handling product complaints and returns. And complete, traceable records must be kept at every step of the way. Our consultants design systems and documentation for proper tracking.