INGREDIENT CERTIFICATION

Ingredients are the first step in the manufacturing process of dietary supplements or natural products and BSCG offers third party certification options to demonstrate they are safe and meet quality standards. Ingredient certification protects against drug contamination, verifies quality and label claims for GMP compliance, and ensures production is done in accordance with GMP or other relevant requirements. The BSCG Certified Drug Free program offers superior banned substance protection in addition to verifying quality specifications and compliance. The BSCG Certified Quality program is an annual certification program that tests for quality specifications, environmental contaminants, and banned substances. BSCG Certified GMP audits verify ingredient provider and manufacturing facilities involved in the production of ingredients comply with 21 CFR 111 Good Manufacturing Practices (GMP). The details involved in ingredient certification for dietary supplements and natural products are outlined below.

A good product starts with quality ingredients, and if you are in the sport nutrition sector it is key to verify that your ingredients comply with anti-doping regulations for sport, military, or first responders. Certified Drug Free is our gold standard program that tests every lot, or monthly, to ensure ingredients are free of  more than 507+ drugs with annual verification of ingredient quality specifications and environmental contaminant testing. An initial compliance audit is conducted prior to certification.

• Ingredient lots are tested for our full menu of 507+ banned substances in sport, prescription, over-the-counter and illicit drugs.
• BSCG industry leading testing menu covers 298 drugs on the WADA Prohibited List, more than any other provider, and 209 other prescription, OTC or illicit drugs no other group covers.
• Covers all the drugs required in Amazon seller central for dietary supplements.
  
• Either every lot, or one lot monthly, must be certified to remain compliant.
• Verification of ingredient specifications by BSCG or another qualified third party is required annually.
  
• Random sampling and testing of ingredients may be conducted at any time.
• Initial toxicology review and ingredient evaluation.
• 21 C.F.R. 111 – GMP quality control process review.
• Client and certified ingredient(s) listed by lot number on the Certified Clients page and database.
• A custom Certified Client page on the BSCG website includes client summary, ingredient images, sales links, and more.
• BSCG Certified Drug Free gold certification program seal can be used on certified ingredient packaging and associated marketing materials.

We know you stand by the quality of your ingredients but third party certification can help you demonstrate that to private label distributors, and accomplish GMP compliance requirements as well. Certified Quality provides annual testing to verify ingredient quality specifications, GMP compliance and screen for banned substances. Strengthen the quality profile for your brand by adding third party certification from BSCG.

• One lot must be tested annually additional lots can be added if needed.
• Ingredient testing verifies quality specifications for identity, purity, strength and composition.
  
• Contaminant testing covers heavy metals, pesticides, and microbiological agents.
• Screening for the BSCG industry leading banned substance testing menu covering more than 500 drugs, including 298 on the WADA Prohibited LIst and 209 Prescription, OTC, or illicit drugs.
• Includes all the drugs required in Amazon seller central for sports nutrition and bodybuilding, sexual enhancement, and weight loss or weight management dietary supplements.
• Standard turnaround time is usually 20 business days after sample receipt.
  
• 21 C.F.R. 111 – GMP quality control process review including; supplier qualification, specifications and testing, and contaminant testing.
• Ingredient brand and certified lot numbers included on BSCG Certified Clients pages and database.
• Certified Client page on BSCG site includes brand summary, lots, images, sales links, and more.
• BSCG Certified Quality blue seal can be used on ingredient packaging and in marketing materials.

Contract manufacturers are the ones that typically seek GMP certification but ingredient suppliers have GMP compliance requirements too.  BSCG Certified GMP for ingredients verifies that the facilities involved in the production of the ingredient 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.

• Initial review of Standard Operating Procedures for the ingredient brand.
• Onsite 21 C.F.R. 111 – GMP audit conducted every two years at the facility(s) that manufacturer the ingredient.
• 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 ingredient provider will be issued a BSCG Certified GMP certificate good for two years for the facility audited.
• Ingredient provider is 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 in ingredient marketing materials.
• Additional assistance with GMP compliance training or procedure development and review is available.