BSCG Certified Quality™ – Program Details

Identity and Label Claim Certification for Dietary Supplements and Natural Products

The BSCG Certified Quality™ certification program offers the gold standard when it comes to identity and label claim certification for dietary supplements and natural products. Our program can be used to verify identity, purity, strength or composition of products or ingredients. The program provides third-party verification of quality specifications to the dietary supplement and natural product industries and allows demonstration of that quality to consumers or clients through use of the BSCG Certified Quality™ seal. The program can be applied to finished products, raw materials and ingredients, or manufacturing facilities. The BSCG Certified Quality™ process for identity and label claim certification for dietary supplements and natural products is outlined below.

Identity and label claim certification for dietary supplements and natural products follows national or international testing standards using methods and guidelines outlined by AHPA, AOAC, NSF ANSI 173, ICH Q3D, Health Canada, USP, EPA, FDA and others. Test methods may include LCMS, GCMS, ICPMS, HPLC, TLC, DNA, microscopy, or other methods as deemed appropriate.

Reports are provided to client companies indicating the relevant unit of nutritional marker(s) with contaminant results shown in comparison to relevant national and international thresholds and guidelines. Certification indicates markers are within acceptable range, and contaminants meet or exceed national and/or international guidelines and/or relevant thresholds (state thresholds like Prop 65 will be shown but not considered from the standpoint of certification).

 

Finished Products – BSCG Certified Quality™ – Details and Process

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.

• 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.

 

Raw Material / Ingredient – BSCG Certified Quality™ – Details and Process

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.

• One raw material / ingredient lot must be tested annually for identity and quality specifications and our full suite of contaminants; heavy metals, pesticides, microbiological agents, and class 1 solvents.
• Toxicology review and risk evaluation.
• 21 C.F.R. 111 – GMP quality control process review of suppliers and qualification process, raw material testing and verification.
• Raw material / ingredient provider listed on BSCG Certified Quality™ Clients page and marketing materials.
• BSCG Certified Quality™ seal can be used on ingredient packaging and marketing materials.

 

Manufacturing Facility – BSCG Certified Quality™ – Details and Process

BSCG Certified Quality™ manufacturing facility certification verifies that supplement contract manufacturers are able to produce products that meet label claims and are free of contaminants. To accomplish this, four finished products and two raw material/ingredient lots are selected at random and tested for a minimum of one or two markers as well as our full suite of contaminants; heavy metals, pesticides, microbiological agents, and 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.

• 4 finished product lots and 2 raw material/ingredient lots are selected at random and tested for a minimum of 1 or 2 markers and our full suite of contaminants; heavy metals, pesticides, microbiological agents, and class 1 solvents.
• Testing is conducted once a year for facilities less 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 over 100,000 sq. ft.
• Raw material / ingredient list review and 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.
• Facility listed on BSCG Certified Quality™ Clients page and marketing materials.
• BSCG Certified Quality™ certification program seal can be used in facility marketing materials.
• The facility can offer the BSCG Certified Quality™ supplement certification program at a discount to downstream finished product brands as an additional service and benefit.