When manufacturing facility certification for dietary supplements and natural products is desired, BSCG offers gold standard protection against drug contamination, quality verification, and GMP audits and compliance. Your facility works hard to ensure quality standards go above and beyond expectations, let the BSCG seals represent that quality to your clients. The BSCG Certified Drug Free® program offers industry leading protection against banned substances in sport as well as other prescription, OTC and illicit drugs. The BSCG Certified Quality™ program conducts quality control and contaminant testing to verify identity and contents of finished products. The BSCG Certified GMP™ conducts third-party on-site audits to ensure facilities comply with 21 CFR 111 Good Manufacturing Practices (GMP). Manufacturing facility certification for dietary supplements and natural products is represented by the gold standard BSCG Certified seals that correspond to each program. The details of each program for manufacturing facility certification are outlined below.
BSCG Certified Drug Free® manufacturing facility certification verifies that supplement contract manufacturers are able qualify raw materials and ingredients so that they are free of drug contamination and produce dietary supplements and natural products that are free of drug contamination. To do so, fifteen finished products are randomly sampled and tested between one and three times per year for our full menu of 485+ drugs (274+ drugs banned in sport and 211+ drugs not banned in sport). Frequency of testing is determined based on size of facility.
BSCG Certified Quality™ manufacturing facility certification verifies that supplement contract manufacturers are able to produce products that meet label claim specifications and are free of contaminants including heavy metals, pesticides, microbiological agents, and solvents according to industry standards. To do so, three finished products and two raw materials / ingredients are randomly selected and tested for a minimum of one or two markers and our full suite of contaminants; heavy metals, pesticides, microbiological agents, class 1 solvents. Testing is conducted annually for facilities smaller than 25,000 sq ft, twice a year for facilities in the 25,000 – 100,000 sq ft range, and three times a year for facilities larger than 100,000 sq ft. A 21 C.F.R. 111 – GMP quality control process review is conducted as well as a raw material/ingredient list and associated risk evaluation.
BSCG Certified GMP™ manufacturing facility certification verifies that supplement contract manufacturers comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP). To do so, an onsite audit is conducted evaluating the various subparts of 21 C.F.R. 111 as they would typically be considered in the course of an FDA GMP audit. Onsite audits are conducted once every two years. A Final Report or an Interim Report and Corrective Action review are provided at the completion of the audit. Additional assistance with GMP training or procedure development and review is available.
Finished products are Certified Drug and Free® with annualFinished products lots are Certified Drug Free® with every batch tested for banned substances and illicit drugs. label claim contaminant testing.
Finished products are Certified Drug & Free® with annual label claim contaminant testing.
Ingredient lot are Certified Drug Free® with for banned substances and illicit drugs.