Finished Product Certification for Dietary Supplements and Natural Products

Testing of Finished Products

BSCG offers third-party finished product certification for dietary supplements and natural products to protect against drug contamination, verify quality, and ensure GMP compliance. The BSCG Certified Drug Free® program offers industry-leading protection against banned substances in sport and other prescription, OTC and illicit drugs. The BSCG Certified Quality™ program conducts quality control and contaminant testing to verify identity and contents. BSCG Certified GMP™ audits facilities involved in the production of dietary supplements and natural products to ensure they comply with 21 CFR 111 Good Manufacturing Practices (GMP). Finished product certification for dietary supplements and natural products is represented by the gold standard BSCG Certified seals that correspond to each program. The options and details for our finished product certification for dietary supplements and natural products is outlined below.

BSCG Certified Drug Free®

BSCG Certified Drug Free® certification offers the maximum drug-testing and toxicology protection to athletes and other elite professionals like police, fire, military, and others who want to ensure their supplements are free of drugs that are prohibited in sport and other prescription, OTC or illicit drugs. Finished products are tested for our full menu of 491+ drugs with 287+ banned substances in sport and 204+ prescription, over-the-counter and illicit drugs. A 21 C.F.R. 111 Good Manufacturing Practices (GMP) quality control process review, ingredient and supplier review and a toxicology assessment are other key elements. Ongoing testing is required with occasional off-the-shelf random testing included.

 

FINISHED PRODUCT – CERTIFICATION DETAILS AND PROCESS

• Finished production lots are tested for our full menu of 491+ banned substances in sport, prescription, over-the-counter, and illicit drugs.
• Every finished batch, or one batch monthly, must be certified with random blind sampling of participating products.
• Testing of off-the-shelf finished products is conducted by BSCG at random.
• Toxicology review and ingredient evaluation.
• 21 C.F.R. 111 – GMP quality control process review.
• Certified products listed by finished lot number on the Banned Substances Control Group (BSCG) Certified Drug Free®database.
• Supplement company included on BSCG Certified Drug Free® Clients page and marketing materials.
• BSCG Certified Drug Free® seal can be used in product manufacturer marketing materials subject to BSCG approval.
• BSCG Certified Drug Free® supplement certification program seal can be used on certified product packages.

 

BSCG Certified Quality™

BSCG Certified Quality™ product certification verifies that supplement products or functional foods meet label claim specifications and are free of contaminants including heavy metals, pesticides, microbiological agents, and solvents according to industry standards. Annual testing is required for a minimum of one or two markers and our full suite of contaminants; heavy metals, pesticides, microbiological agents, class 1 solvents. 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.

 

FINISHED PRODUCT – CERTIFICATION DETAILS AND PROCESS

• One finished product lot must be tested annually for a minimum of 1 or 2 nutritional markers and our full suite of contaminants; heavy metals, pesticides, microbiological agents, and class 1 solvents.
• Additional nutritional markers or lots can be added if desired.
• Toxicology review and ingredient risk evaluation.
• 21 C.F.R. 111 – GMP quality control process review of suppliers and qualification process, raw material testing and verification, and finished product testing and verification.
• Finished product listed on BSCG Certified Quality™ Clients page and marketing materials.
• BSCG Certified Quality™ seal can be used on packaging and marketing materials.

 

BSCG Certified GMP™

BSCG Certified GMP™ for finished products verifies that the facilities involved in the production of finished products 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 production are conducted evaluating the various subparts of 21 C.F.R. 111 as they would typically be considered in the course of a 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 in the event that deficiencies are identified.

 

FINISHED PRODUCT – CERTIFICATION DETAILS AND PROCESS

• Onsite 21 C.F.R. 111 – GMP audit conducted every two years at the facility(s) that manufacturer the finished dietary supplement or natural product.
• Final Report or Interim Report and Corrective Action Review issued after audit.
• Any observations will be broken down into critical, major, minor, and recommendations.
• Once all critical and major observations are resolved a Final Report will be provided and the finished product client will be issued a BSCG Certified GMP™ certificate good for two years for the facility audited.
• Finished dietary supplement product are listed on BSCG Certified GMP™ Clients page and marketing materials once all facilities involved in production are audited.
• Onsite audits are billed on an hourly basis based on the actual time spent auditing and preparing the review and reports.
• Client is responsible for travel expenses related to the assessment including economy class airfare, rental car, hotel, meals, taxes, tolls, etc.
• BSCG Certified GMP™ seal can be used in finished dietary supplement or natural product marketing materials.
• Additional assistance with GMP compliance training or procedure development and review is available.