PRODUCT CERTIFICATION FOR DIETARY SUPPLEMENTS AND NATURAL PRODUCTS

BSCG offers third-party product certification for dietary supplements and natural products focused on banned substances, label claims, and GMP compliance. The BSCG Certified Drug Free program offers industry-leading anti-doping protection for sport, military, and first responders that also includes label claim verification and GMP compliance providing premium supplement options for any consumer. The BSCG Certified Quality program is designed for retail and consumer protection with annual screening for banned substances, label claims, and contaminants. BSCG Certified GMP audits private label distributors and facilities involved in the production of dietary supplements and natural products to ensure they comply with 21 CFR 111 Good Manufacturing Practices (GMP) for dietary supplements or other relevant GMP or regional requirements. Details on our product certification for dietary supplements and natural products is outlined below.

BSCG Certified Drug Free product certification for dietary supplements and natural products offers the maximum drug-testing 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 or other prescription, OTC or illicit drugs. Every lot is tested for our industry leading banned substance testing menu cover more than 507+ banned substances in sport, 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 included in the initial certification process. Label claim and contaminant specifications are verified annually. Occasional off-the-shelf random testing may be done at any time.

• Every finished production lot is tested for our industry leading testing menu covering more than 507+ drugs including 298 on the WADA Prohibited List and 209 prescription, OTC or illicit drugs.
• Manufacturer must be audited for GMP by BSCG or another qualified third-party at a minimum every two years, or otherwise demonstrate compliance with relevant qualifications in the region of sale.
  
• Product specifications for label claims and contaminants must be verified annually by BSCG or a qualified third-party, the Certified Quality program can be added to fulfill this requirement.
  
• Initial formula evaluation considers general toxicology, banned substance issues and ingredient compliance.
• In depth audit of labels, claims, and quality control focused on supplier qualification, ingredients specifications and testing, finished product specifications and testing, adverse event reporting, and recall procedures.
• Certified products and lot numbers listed in Certified Drug Free database.
• Certified Clients page created with product images, category, goals, sales links, barcode data, contacts and more.
  
• Brand logo included on BSCG Certified Drug Free Clients page and marketing materials.
• Certified Drug Free gold seal can be used on packaging and in marketing materials subject to BSCG approval.
• Random purchases and testing of off-the-shelf items may be conducted at any time.
  

BSCG Certified Quality is an annual third-party product certification designed for retail and consumer protection. It includes testing for label claim specifications, environmental contaminants, and more than 507 banned substances. Annual testing typically covers two nutritional markers and our full suite of contaminants; heavy metals, pesticides, and microbiological agents, and our industry leading banned substance testing menu. Initial certification process includes a claims, compliance, and GMP quality control process review. Don't just tell your retailers or customers that products meet label claims and are free of contaminants, show them with Certified Quality.

• One product lot of each participating product must be tested annually, additional lots may be tested as needed.
• Label claim testing includes verification of one or two ingredient specifications or nutrient markers, additional ingredients can be added a la carte.
  
• Environmental contaminant testing includes heavy metals, pesticides, and microbiological agents.
• Screening for our industry leading banned substance testing menu covering more than 507 banned substances in sport and other prescription, OTC, or illicit drugs (covers all the drugs required in Amazon seller central for dietary supplements).
• Manufacturer must be audited for GMP by BSCG or another qualified third-party at a minimum every two years, or otherwise demonstrate compliance with relevant qualifications in the region of sale.
  
• In depth audit of quality control process, suppliers and qualification process, raw material testing and verification, and finished product testing and verification, recall and adverse event reporting procedures and more.
• Initial formula evaluation considers general toxicology, banned substance and ingredient compliance issues.
  
• Product and lots listed on BSCG Certified Quality Clients page and marketing materials with reports available publicly.
• Certified Quality blue seal can be used on packaging and marketing materials.

BSCG Certified GMP for finished products verifies that private label distributors have the required SOPs and documents in place and that the facilities involved in the production comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP) for dietary supplements, or other relevant GMP or regional qualifications. Private label distributor SOP review is conducted by a document audit while onsite audits of facilities evaluates the various subparts of GMP as they would typically be considered in the course of a regulatory audit. Onsite audits are conducted 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 as needed.

• Complete SOP review for private label distributor is conducted by document audit.
  
• 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 products 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 red seal can be used on finished product dietary supplement or natural product packaging and marketing materials.
• Additional assistance with GMP compliance training or procedure development and review is available.