Raw Material and Ingredient Certification

Testing and Certification of Raw Materials and Ingredients of Dietary Supplements and Natural Products

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^®

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 491+ drugs with 287+ banned substances in sport and 204+ prescription, over-the-counter and illicit drugs. 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.

RAW MATERIAL / INGREDIENT – CERTIFICATION DETAILS AND PROCESS

Raw material / ingredient lots 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 minimum of one lot quarterly must be certified to remain compliant.
Random sampling and testing of ingredients may be conducted at any time.
Toxicology review and ingredient evaluation.
21 C.F.R. 111 – GMP quality control process review.
Certified raw material/ingredient listed by lot number on the BSCG Certified Drug Free® database.
Raw material/ingredient provider included on BSCG Certified Drug Free® Clients page and marketing materials.
BSCG Certified Drug Free® certification program seal can be used on certified raw material / ingredient and associated marketing materials.

BSCG Certified Quality™

BSCG Certified Quality raw material / ingredient certification ensures the components of dietary supplements, nutritional supplements, natural products, and other related categories 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.

RAW MATERIAL / INGREDIENT – CERTIFICATION DETAILS AND PROCESS

One ingredient lot must be tested annually for verification of specifications and contaminants
including a minimum of 1 or 2 markers and our full suite of contaminants; heavy metals, pesticides,
microbiological agents, and class 1 solvents.
Additional markers or lots can be tested for at any time based on client needs.
Toxicology review and ingredient risk evaluation.
21 C.F.R. 111 – GMP quality control process review including; supplier qualification, specifications and testing, and contaminant testing.
Certified ingredients listed by finished lot number on the BSCG Certified Database.
Ingredient provider included on BSCG Certified Clients page and marketing materials.
BSCG Certified Quality™ seal can be used on ingredient packaging and in marketing materials.

BSCG Certified GMP™

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.

RAW MATERIAL / INGREDIENT – CERTIFICATION DETAILS AND PROCESS

Onsite 21 C.F.R. 111 – GMP audit conducted every two years at the facility(s) that manufacturer the raw material/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 raw material / ingredient provider will be issued a BSCG Certified GMP™ certificate good for two years for the facility audited.
Raw material / 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™ seal can be used in raw material / ingredient marketing materials.
Additional assistance with GMP compliance training or procedure development and review is available.