At BodyHealth, quality is built through a fully integrated, risk-based system aligned with regulatory expectations for dietary supplements and food products. Our approach is grounded in Hazard Analysis and Critical Control Point (HACCP) principles and current Good Manufacturing Practices (cGMP), ensuring consistent product safety, identity, strength, and purity from raw material sourcing through finished product distribution.
All manufacturing facilities utilized are cGMP-certified, ensuring compliance with United States Food and Drug Administration (FDA) regulatory requirements. In addition, many of our products are independently verified under NSF International programs, including NSF Content Certified and Certified for Sport®, demonstrating label claim accuracy and freedom from banned substances.
An independent Quality Assurance / Quality Control (QA/QC) unit operates with full authority over product release decisions. This unit functions autonomously from manufacturing operations to maintain objectivity, prevent conflicts of interest, and ensure product integrity.
Our program operates in compliance with Title 21 Code of Federal Regulations (21 CFR), including Part 111 (Dietary Supplement cGMP) and Part 117 (Food cGMP and Preventive Controls). It incorporates the Food Safety Modernization Act (FSMA) and is managed by Preventive Controls Qualified Individuals (PCQIs).
A fully integrated Food Safety Plan includes:
Suppliers are qualified using a risk-based approach considering ingredient type, country of origin, regulatory history, and potential for fraud.
Qualification activities include:
All incoming materials are required to meet defined specifications for identity, purity, strength, and composition. Reliance solely on Certificates of Analysis (COAs) is insufficient; confirmatory and identity testing is routinely performed.
Foreign suppliers are managed under the Foreign Supplier Verification Program (FSVP), where applicable.
All materials are received under quarantine with barcode traceability and undergo inspection and testing prior to release.
Analytical testing includes:
In addition to identity and contaminant testing, selected raw materials undergo Strength and Potency Verification to confirm quantitative composition and label claim alignment where applicable.
Manufacturing operations occur in controlled environments with:
All critical instruments and systems undergo routine calibration, maintenance, and qualification.
Each dosage form is monitored with defined in-process controls to ensure consistency and compliance:
Finished products are evaluated prior to release, including:
Final batch release is completed only after full review of the Batch Production Record (BPR), any deviations and Corrective and Preventive Actions (CAPA), and all analytical test results. A final Certificate of Analysis (COA) is issued.
Where applicable, analytical testing is performed by qualified laboratories operating under ISO/IEC 17025-accredited quality systems. These laboratories maintain validated analytical methods, calibrated instrumentation, documented data integrity controls, and established proficiency standards to support the accuracy, reliability, and traceability of test results. Utilization of ISO/IEC 17025-accredited laboratories provides additional assurance that analytical activities are conducted in accordance with internationally recognized laboratory competence requirements.
A comprehensive complaint handling system classifies and investigates all feedback, including potential adverse events. Trends are monitored to identify systemic risks.
Recall readiness is maintained through documented plans and mock recall exercises to ensure rapid and effective response if required.
Our analytical and manufacturing capabilities include:
Digital systems support electronic Batch Production Records (eBPR), Master Manufacturing Records (MMR), and fully integrated deviation and change control processes.
Dedicated personnel support the quality system, including:
Each role contributes to maintaining a robust, compliant, and continuously improving quality system aligned with regulatory expectations and industry best practices.