Quality Standards

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Quality Standards *

Quality Standards

At Sanozen, quality is at the core of everything we do. We are committed to upholding the highest standards for ourselves and our customers. Led by industry-experienced professionals, our quality processes are driven by continuous improvement, ensuring we consistently deliver the best results.

Our entire team is dedicated to surpassing basic FDA compliance standards for current Good Manufacturing Practices (cGMP). We’ve designed our systems to ensure every product meets rigorous safety, purity, and potency standards, setting our customers up for success in the marketplace.

Two female scientists wearing white lab coats, hair nets, safety glasses, masks, and gloves standing in a laboratory, holding tablets and discussing their work.

Sanozen is registered with the U.S. FDA and fully compliant with 21 CFR Part 111. In addition to this, we’ve made significant investments to support our customers with certifications, memberships, and licenses, including:

  • GMP, Quality, and Regulatory Certifications: NSF, GRMA.

We take pride in sharing our active status with these third-party certifications:

  • The newly developed ‘455’ standards incorporate current GMPs and regulatory requirements in addition to best industry practices per retailer requirements. This progression from the soon-to-be-obsolete ‘173’ certification supports a modernized approach to quality management, as the new national standard is a result of collaborative efforts among varying experts and industry perspectives following the ISO 9001 organization with the overall objective of improving product safety for consumers.

  • The new ‘306’ standards call for more proactive and demonstrable oversight and control by the manufacturer to ensure that the facility is free from substances prohibited in competitive athletics. This certification compliments Columbia Nutritional’s Informed Manufacturer certification to maintain an unparalleled commitment to sports nutrition and mitigation of cross-contamination from supply chain through production.

  • This organization combines the collective interests and perspectives of retailers, manufacturers, laboratories, and has established a unified certification program to recognize a select few third-party standards that meet their requirements for quality manufacturing – Including NSF-455. Our membership and active facility certification allow us to live into our value of transparency and integrity, and collaborate among other leaders in producing safe, compliant, and high-quality supplements for maximum consumer protection.

  • With quality and regulatory compliance at the core of everything we do, our Quality Systems include a robust collection of procedures and policies established to ensure consistent manufacturing of high-quality supplements. While the organization has been established for decades, our processes are continuously evaluated and evolved to stay at the leading edge of regulatory requirements, industry guidelines and best practices, and new scientific evidence.

    Some examples of the foundational programs that are maintained for uncompromised product quality and safety include:

    • Controlled Specifications for all Ingredients, Components, and Finished Products

    • In-Process Specifications and Statistically Based QC Inspections

    • Risk-Based Raw Material and Finished Product Testing

    • Laboratory Qualification Program

    • Allergen Control Program

    • Food Safety Plan and Hazard Analysis

    • Raw Material Risk Assessment Program

    • Supplier Qualification Program

    • Sanitation Program and Master Sanitation Schedule

    • Cleaning Validation Program

    • CAPA Program

    • Routine Training for All Staff on GMPs, GDPs, and Food Handling, Handling, and Safety