MANUFACTURING FACILITY CERTIFICATION FOR DIETARY SUPPLEMENTS AND NATURAL PRODUCTS
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. Our manufacturing facility certification for the dietary supplement and natural product industry offers unique benefits in the form of downstream benefits to your clients. Our new Certified Facility program includes GMP compliance, quality control testing, and banned substance screening in one program. Our Certified GMP program focuses on GMP compliance only with onsite audits done every two years, a cost and time efficient approach. The details of each manufacturing facility certification for dietary supplements and natural products are outlined below.
BSCG CERTIFIED GMP
Provides onsite audits of manufacturing, packaging or holding facilities to verify compliance with GMP according to the requirements outlined in 21 CFR 101, 111, 117. We offer a two year audit cycle decreasing the burden on the facility. Certified GMP proves to brands that a facility complies with the laws and regulations outlined in GMP. We also allow licensing of the seal to your clients and discounts to those that wish to join our product certification programs.
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.
- Downstream benefits to clients include the possibility of licensing the BSCG Certified GMP seal or discounts if they want to join one of our product certification programs.
BSCG CERTIFIED FACILITY
BSCG Certified Facility is a new unique certification concept for facilities that encompasses GMP compliance, quality control and ingredient verification testing, and screening for our industry leading banned substance testing menu cover more than 500 drugs. Go above and beyond facility GMP certification with the Certified Facility program that shows customers that a facility makes products that meet label claims and are free of banned substances and environmental contaminants. your clients get added benefits as well with discounts offered on the initial cost of certification.
- Certification requires a GMP audit by BSCG or another qualified third-party, or demonstration of compliance with other relevant regional requirements.
- In depth review of the list of Standard Operating Procedures (SOP) and key SOP documents.
- Comprehensive review and risk evaluation on the list of ingredients available at the facility to consider banned substance and ingredient compliance.
- Quarterly testing of one randomly selected product to verify label claims, screen for banned substances, and heavy metals, pesticides, and microbiological agents.
- If out of specification results are found a follow up testing plan will be created to further evaluate and address the issue.
- Industry leading banned substance testing covers 507+ drugs with 298 on the WADA Prohibited List and 209 other prescription, OTC or illicit drugs (Includes all drugs required in Amazon seller central for dietary supplements). A la carte testing available as needed at a 10% discount off our standard rate.
- Facility listed on Certified Facility page and BSCG marketing materials.
- Certified Facility purple seal can be used in manufacturer marketing materials.
- As an added benefit, facility can offer a 20% discount on the initial cost of certification to clients that want to join our finished product certification programs.