Quality Control and Assurance
Quality Assurance & Quality Control
Kirkman® employs skilled and well-trained quality assurance and quality control staff. They operate independently of manufacturing with full authority to ensure that Kirkman's products are manufactured in compliance with the highest industry, regulatory, and internal standards. This authority begins with the receipt of materials and components and continues through the manufacturing, testing, packaging, storing, and shipping operations. Kirkman's 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 Kirkman's extensive Standard Operating Procedures (SOPs).
Quality Assurance Activities
Kirkman's quality assurance (QA) staff is tasked with ensuring that our processes and control systems are defined and appropriate so that Kirkman's 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. Kirkman is cGMP certified.
In addition, Kirkman's 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 Kirkman's manufacturing process.
An important part of quality assurance is validating our raw ingredient and materials suppliers. Kirkman sources only premium 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 Kirkman's rigorous standards of product testing and quality. Suppliers are reviewed and re-qualified on a regular basis.
Kirkman holds our 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.
Kirkman's Ultra Tested® Testing Protocol
Kirkman quality standards far exceed FDA cGMP's Guidelines for nutritional supplements throughout our processes and procedures. In the area of testing, Kirkman's protocols are unmatched in the nutritional supplement industry and far exceed FDA requirements. Our comprehensive Ultra Tested protocol ensures that our products are tested for safe levels of 24 heavy metals — aluminum, antimony, arsenic, beryllium, barium, cadmium, chromium, copper, cobalt, lead, manganese, mercury, molybdenum, palladium, platinum, selenium, thallium, tin, tungsten, uranium, vanadium, zinc, nickel, and silver.
Quality Control Activities
Kirkman's quality control (QC) staff enforce Kirkman's planned and systematic operations for ensuring the quality and safety of all the products we manufacture. They 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.
Kirkman's 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. Kirkman's rigorous QA/QC programs ensure our customers that Kirkman's products are produced in accordance with the highest quality standards.