We employ skilled and well-trained quality assurance and quality control staff. They operate independently of the manufacturing staff and have full authority to ensure that our products are manufactured in compliance with the highest industry, regulatory, and internal standards. This begins with the receipt of materials and components and continues through the manufacturing, testing, packaging, storing, and shipping operations. Functional Brands’ QA/QC staff are fully authorized to reject raw materials or finished product if any quality problems are found, or to stop production for non-compliance with our extensive Standard Operating Procedures (SOPs).
Quality Assurance Activities
Functional Brands’ quality assurance (QA) staff is tasked with ensuring that our processes and control systems are defined and appropriate so that your products consistently meet the established specifications for identity, purity, strength, composition, and limits on contaminants and are manufactured, packaged, labeled, and stored under conditions that prevent adulteration. These processes and controls are those outlined by the FDA’s Current Good Manufacturing Practices (cGMPs) as defined in the Code of Federal Regulations Section 21-Part 111. Our facility is cGMP certified.
The QA staff continually monitors and audits employee training, cleanliness of the facility, documentation, records, equipment, and SOPs to ensure consistency and safety in every aspect of Functional Brands’ manufacturing process.
We source only premium raw ingredients that come from well-established suppliers known to supply top quality ingredients to the industry. In addition to requiring Certificates of Analysis that certify the quality and purity of ingredients provided, suppliers must also meet our rigorous standards of product testing and quality. Suppliers are reviewed and re-qualified on a regular basis. Functional Brands Supplements holds its suppliers to the highest standards by following strict pharmaceutical manufacturing guidelines. Our ingredients are selected solely on the basis of quality and purity. Every incoming lot of raw material is positively identified as the correct material by near infrared spectroscopy. This eliminates any potential errors in material selection or shipping errors by a supplier.
Quality Control Activities
Functional Brands’ quality control (QC) staff enforce its planned and systematic operations for ensuring the quality and safety of all the products we manufacture. We monitor each step of every manufacturing procedure for compliance including:
- inspecting all raw ingredients, components and labels;
- monitoring product testing activities and reviewing testing results;
verifying cleanliness and sanitation conditions of manufacturing and packaging areas before manufacturing and packaging begins; - verifying the identity and quantity of all ingredients in a formula;
- verifying accurate weights of capsules and divts during manufacturing;
- verifying accurate fills and counts during the packaging process;
- reviewing and releasing all products packaged to finished goods inventory;
- monitoring the completeness and accuracy of shipping records for any potential recall.
Our QA/QC activities continue even after a product is manufactured, tested and shipped. We conduct an ongoing product stability program to monitor all active ingredients in all products throughout the shelf life of the product, which is reflected in the “best used by” date. Our QA/QC professionals are skilled in ensuring consistent compliance with our industry leading comprehensive quality system and FDA cGMPs for every aspect of nutritional supplement production. Functional Brands’ rigorous QA/QC programs ensure our customers that our products are produced in accordance with the highest quality standards.