Manufacturing Facility Certification for Dietary Supplements and Natural Products

GMP Audits and Compliance

When manufacturing facility certification for dietary supplements and natural products is desired, BSCG offers gold standard protection against drug contamination, quality verification, and GMP audits and compliance. Your facility works hard to ensure quality standards go above and beyond expectations, let the BSCG seals represent that quality to your clients. The BSCG Certified Drug Free^® program offers industry leading protection 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 finished products. The BSCG Certified GMP™ conducts third-party on-site audits to ensure facilities comply with 21 CFR 111 Good Manufacturing Practices (GMP). Manufacturing facility certification for dietary supplements and natural products is represented by the gold standard BSCG Certified seals that correspond to each program. The details of each program for manufacturing facility certification are outlined below.

BSCG Certified Drug Free^®

BSCG Certified Drug Free^® manufacturing facility certification verifies that supplement contract manufacturers are able qualify raw materials and ingredients so that they are free of drug contamination and produce dietary supplements and natural products that are free of drug contamination. To do so, fifteen finished products are randomly sampled and tested between one and three times per year for our full menu of 496+ banned substances in sport, prescription, over-the-counter and illicit drugs. Frequency of testing is determined based on size of facility.

MANUFACTURING FACILITY – CERTIFICATION DETAILS AND PROCESS

15 finished product lots are selected at random and tested for our full menu of 496+ banned substances in sport, prescription, over-the-counter and illicit drugs.
The above testing is conducted once per year for facilities up to 25,000 sq ft, twice per year for facilities in the 25,000 – 100,000 sq ft range, three times per year for facilities over 100,000 sq ft.
Additional testing of finished product lots that follow production of products containing any known banned substances or pharmaceutical agents of concern.
Raw material / ingredient list and product 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 Drug Free^®Clients page and marketing materials.
BSCG Certified Drug Free^®certification program seal can be used in facility marketing materials.
The facility can offer BSCG Certified Drug Free® supplement certification program at a discount to downstream product brands as an additional service and benefit. BSCG Certified GMP™ program is required in order to offer BSCG Certified Drug Free® downstream.

BSCG Certified Quality™

BSCG Certified Quality™ manufacturing facility certification verifies that supplement contract manufacturers are able to produce products that meet label claim specifications and are free of contaminants including heavy metals, pesticides, microbiological agents, and solvents according to industry standards. To do so, three finished products and two raw materials / ingredients are randomly selected and tested for a minimum of one or two markers and our full suite of contaminants; heavy metals, pesticides, microbiological agents, 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.

MANUFACTURING FACILITY – CERTIFICATION DETAILS AND PROCESS

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.

BSCG Certified GMP™

BSCG Certified GMP™ manufacturing facility certification verifies that supplement contract manufacturers comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP). To do so, an onsite audit is 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.

MANUFACTURING FACILITY – CERTIFICATION DETAILS AND PROCESS

Onsite 21 C.F.R. 111 – GMP audit conducted every two years.
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 facility will be issued a BSCG Certified GMP™ certificate good for two years.
Facility listed on BSCG Certified GMP™ Clients page and marketing materials.
BSCG Certified GMP™ seal can be used in facility marketing materials.
Onsite audits are billed on an hourly basis based on the actual time spent auditing and preparing the review and reports.
Facility is responsible for travel expenses related to the assessment including economy class airfare, rental car, hotel, meals, taxes, tolls, etc.
Additional assistance with GMP compliance training or procedure development and review is available.