BSCG Certified GMP – GMP Certification, Compliance, and Auditing

BSCG Certified GMP™ – Details and Process

GMP Certification, Compliance and Auditing

The BSCG Certified GMP™ supplement certification program offers the gold standard in GMP certification, compliance and auditing for 21 C.F.R. 111 – Current Good Manufacturing Practices (GMP). For finished product or raw material/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. 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 21 CFR 111 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.

BSCG provides GMP certification to participating companies that indicates the finished product, raw material / ingredient, or facility is in compliance with 21 CFR 111 GMP upon successful completion of the onsite audit and follow-up evaluation. The GMP certification will be valid for two years. Participating company will be able to use the BSCG Certified GMP™ seal to indicate GMP certification, compliance and audit verification. The BSCG Certified GMP™ program, compliance and auditing process is outlined below.

 

Finished Products – BSCG Certified GMP™ – Details and Process

BSCG Certified GMP™ for finished products verifies that the facilities involved in the production of finished products comply with the requirements as set forth in 21 C.F.R. 111 – Current Good Manufacturing Practice (GMP). To accomplish this, onsite audits of the facilities involved in production 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 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 in the event that deficiencies are identified.

• Onsite 21 C.F.R. 111 – GMP audit conducted every two years at the facility(s) that manufacturer the finished dietary supplement or natural product.
• 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 finished product client will be issued a BSCG Certified GMP™ certificate good for two years for the facility audited.
• Finished dietary supplement product 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™ 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.

 

Raw Material / Ingredient – BSCG Certified GMP™ – Details and Process

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 accomplish this, onsite audits of the facilities involved in raw material production are conducted evaluating the various sub-parts 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.

• 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.

 

Manufacturing or Holding Facilities – BSCG Certified GMP™ – Details and Process

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). To accomplish this, an onsite audit is conducted evaluating the various sub-parts of 21 C.F.R. 111 GMP 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 compliance training or procedure development and review is available.

• 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.