Kirkman® employs skilled and well-trained quality assurance and quality control staffs. 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 GMP certified by NSF.
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 requalified on a regular basis.
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.
Our Ultra Tested™ protocol includes testing every batch of
our products for the absence of common allergens including casein,
gluten, soy and peanuts, plus the absence of harmful levels of bacteria,
yeast and mold, including E.coli, Salmonella, Staphlococcus aureus,
Pseudomonas, Listeria, Enterococcus and other coliform bacteria.
In addition, Kirkman's testing protocol includes testing for
the absence of more than 900 pesticides, herbicides, insecticides,
fungicides, biocides, endocrine disruptors and other harmful chemicals. Kirkman® is
the only supplement company that provides this degree of testing to
ensure the purity and safety of our products.
Quality Control Activities
Our quality control (QC) staff enforce Kirkman's planned and systematic operations for ensuring the quality and safety of all the products we manufacture.
Our experienced QC staff monitors each step of every manufacturing procedure for compliance including:
• inspecting all raw ingredients,
components and labels;
• monitoring product testing
activities and reviewing testing
• verifying cleanliness and
sanitation conditions of
manufacturing and packaging
areas before manufacturing and
• verifying the identity and
quantity of all ingredients in
• verifying accurate weights of
capsules and tablets during
• verifying accurate fills and
counts during the packaging
• reviewing and releasing all
products packaged to finished
• 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.