Raw materials and ingredients are the first step in the manufacturing process of dietary supplements or natural products. Make sure yours is BSCG Certified for to ensure protection against drug contamination, verification of quality and label claims, as well as manufactured in a facility with audited GMP. Raw material and ingredient certification for dietary supplements and natural products is available for your every need with BSCG. The BSCG Certified Drug Free® program protects raw materials and ingredients 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 your raw material / ingredient. BSCG Certified GMP™ audits facilities involved in the production of raw materials / ingredients to ensure compliance with 21 CFR 111 Good Manufacturing Practices (GMP). Raw material and ingredient certification for dietary supplements and natural products is represented by the gold standard BSCG Certified seals that correspond to each program. The details of certification for raw materials and ingredients used in dietary supplements and natural products are outlined below.
BSCG Certified Drug Free® raw material and ingredient certification brings our protection down a level in the manufacturing chain to ensure that the components of dietary supplements or functional foods are free of drug contamination prior to formulation in a finished product. Ingredients lots are tested for our full menu of 496+ drugs (276 drugs banned in sport and 220+ drugs not banned in sport). A 21 C.F.R. 111 – GMP quality control process review, ingredient and supplier review, and a toxicology assessment are other key elements. Ongoing testing is required.
BSCG Certified Quality™ raw material / ingredient certification ensures the components of dietary supplements or functional foods are verified for identity, purity, strength, or composition. Lots of participating raw materials/ingredients are tested for markers in order to validate whether or not they meet quality control identification specifications and are free of contaminants including heavy metals, pesticides, microbiological agents, and solvents.
BSCG Certified GMP™ for raw material or ingredient certification verifies that the facilities involved in the production of the raw material comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP). To do so, onsite audits of the facilities involved in raw material production are 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.
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