BSCG CERTIFIED GMP – GMP CERTIFICATION, COMPLIANCE, AND AUDITING

The BSCG Certified GMP program offers a cost effective GMP certification that includes benefits for manufacturers and a GMP compliance check and marketing benefits to brands or ingredient providers. We conduct compliance audits for 21 C.F.R. 111 – Current Good Manufacturing Practices (GMP) for dietary supplements. We can also audit for other GMP guidelines including 210, 211 for drug products or cosmetic guidelines.

finished product or ingredient certification we audit the facilities involved in the production of the product or ingredient to verify GMP compliance in order for the product or ingredient provider to carry the BSCG Certified GMP seal. In the case of manufacturing facilities, the facility is audited for GMP compliance and, if successful, is able to use the BSCG Certified GMP seal to showcase GMP compliance.

Program participation requires each manufacturing or holding facility to be evaluated for  GMP compliance. The evaluation includes a third-party onsite audit conducted every two years, providing for a cost effective solution. Upon completion of the GMP audit the participating company receives a comprehensive review from BSCG of all key audit criteria with recommendations for corrective actions to be in compliance with GMP.  Once the participating company notifies BSCG that solutions are in place for any corrective actions noted, a follow-up evaluation will be scheduled by phone or video conference to review any deficiencies and evaluate the corrective actions taken. A Certified GMP certificate is provided once all issues have been addressed.

Participating companies will be able to use the BSCG Certified GMP and will have their certificate, contact information and other details included in our database and on a custom Client page.

BSCG Certified GMP for finished products or ingredients verifies 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), or other relevant GMP or regional requirements. To accomplish this, onsite audits of the facilities are conducted evaluating the various sub-parts of 21 C.F.R. 111 as they would typically be considered in the course of a GMP 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 in the event that deficiencies are identified.

• Onsite audit conducted every two years at the facility(s) that manufacturer the dietary supplement or natural product or 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 brand will be issued a BSCG Certified GMP certificate good for two years for the facility audited.
• Clients 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 in finished dietary supplement or natural product marketing materials.
• Additional assistance with GMP compliance training or procedure development and review is available.

BSCG Certified GMP manufacturing facility certification verifies that contract manufacturers or other holding facilities comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP), or other relevant GMP or regional requirements. To accomplish this, an onsite audit is conducted evaluating the various sub-parts of GMP as they would typically be considered in the course of an FDA GMP 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 compliance training or procedure development and review is available.

• Onsite 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 red 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.