[Commitment to Excellence] Kamerycah Audits the Toyama Manufacturing Plant to Ensure Strict cGMP Compliance
[Commitment to Excellence] Kamerycah Audits the Toyama Manufacturing Plant to Ensure Strict cGMP Compliance
When choosing a supplement, ingredients are only one part of the story. Many customers also ask: Are the raw materials thoroughly screened? Is the production environment truly hygienic? Is the quality of every single capsule consistent? Is the bottle count accurate?
To provide our customers with total peace of mind, Kamerycah recently visited the manufacturing plant in Toyama Prefecture, Japan. Our team conducted a comprehensive quality audit of the products supplied to the U.S. market, based on the current Good Manufacturing Practices for Dietary Supplements (cGMP, 21 CFR Part 111). From raw material intake and production to bottling and shipping, we personally inspected every step to ensure that all management measures are rigorously implemented on the factory floor.
World-Class Certifications: Multi-Layered Third-Party Validation
The manufacturer holds several internationally recognized certifications for manufacturing and food safety, providing a solid foundation for its quality management:
◾JHNFA (Japan Health Food GMP): Covering manufacturing and quality management requirements for health foods.
◾FSSC 22000 Food Safety System Certification: Audited by LRQA, focusing on the identification, control, and continuous management of food safety risks.
◾NSF Dietary Supplement GMP Certification: Evaluated based on the NSF/ANSI 455-2 standard for manufacturing and quality systems.
◾UL Solutions cGMP Certificate of Inspection: Within the dietary supplement manufacturing and packaging scope specified in the certificate, the relevant facility has passed a third-party inspection against U.S. cGMP requirements (including 21 CFR Part 111) and applicable GMP standards.
◾Informed Manufacturer Certification: Reducing the risk of prohibited substance contamination through quality system assessments and regular testing.
Raw Material Integrity: Validation Before Production
Quality begins with the raw materials. Before production commences, all materials undergo strict inspection to ensure they meet all specifications before weighing and mixing. We focused on receipt, identification, and storage methods, ensuring that materials are stored safely and accurately identified. Utilizing advanced equipment such as FT-IR (Fourier-Transform Infrared Spectroscopy), the plant ensures that only the correct, pure raw materials enter the production line.
Environmental Hygiene: Comprehensive Control from Personnel to Air
Hygiene management starts at the entrance. Our audit covered gowning procedures, hand-washing, air showers, and employee health management, as well as equipment cleaning, water quality, and systematic pest control.
Regarding pest management, we focused on "trend monitoring" rather than just "results." By reviewing equipment layout, continuous logs of capture counts, and collaborations with external professional firms, the plant ensures it can detect risks early and implement preventative measures to minimize contamination. Furthermore, "positive pressure management" is used to maintain higher air pressure within production areas, effectively blocking external dust and contaminated air. Additionally, protein residue testing after cleaning helps minimize the risk of cross-contamination between different products.
Precision Quality: Ensuring Every Capsule is Stable
From mixing and filling to screening, every process is governed by strict control conditions:
◾ Weight and Appearance Checks: Real-time monitoring of filling status to detect any breakage or abnormalities.
◾ Disintegration Testing: Confirming that capsules disintegrate within the specified time and conditions, ensuring the active ingredients are properly released.
◾ Foreign Object Prevention: Using metal detectors or X-ray equipment to minimize the risk of foreign materials entering the product.
Accurate Counting: Dual-Layer Verification (Human & Machine)
In the bottling area, automated machinery is complemented by dedicated staff who monitor the process in real-time. Every bottle must contain exactly 120 capsules; if a bottle is found to be under-filled, it is immediately removed to prevent it from reaching the packaging stage. This "human-machine collaboration" ensures that the quantity in every bottle you receive is accurate.
Traceability: From Quality Release to Post-Shipment Tracking
After production, products undergo final quality testing and a "release for shipment" determination. Through precise batch/lot management, we can trace the production time, the specific raw materials used, and the entire manufacturing process. The plant also maintains a retention sample system, allowing any quality query to be re-tested and verified against a saved sample of that specific batch.
Continuous Improvement: Our Responsibility to the Customer
Personally visiting the manufacturing sites and understanding the details behind our products is Kamerycah's commitment to our customers. We will continue to partner with top-tier Japanese plants, utilizing on-site audits and continuous tracking to safeguard the quality and health of every product we deliver.
Want to learn more about our commitment to quality? Explore our product range today.
