cGMP Quality Compliance Report

Excelsior Alchemy takes quality compliance seriously. Our goal is produce the highest quality products in the industry.

Our production facility is registered with the Food and Drug Administration (FDA) and is routinely inspected. We follow FDA CFR 111 Current Good Manufacturing Practices in manufacturing, packaging, labeling, or holding operations for dietary supplements. Additionally, we continually work with label consultants to ensure FDA label compliance.

Our production facility does extensive testing of all ingredients, above and beyond regulatory requirements. Every incoming ingredient is tested for identity, micro-contamination, and heavy metals. The same tests are done on the finished blend, and further tests are done on the finished product. We are using the latest HP-TLC (High Performance Thin Layer Chromatography) and FTIR technology to ensure that only the highest quality ingredients are used. For an ingredient to be used in one of our products, the supplier must be qualified first through an extensive questionnaire which is then followed up by third-party Certificate of Analysis testing. Additionally, our facility only uses 100% non-toxic, organic compliant, and biodegradable cleaning chemicals (far beyond what is required by USDA Organic). Our production area is a radio frequency-free zone (no microwaves, Wi-Fi, or cell phones permitted) and has electromagnetic radiation (EMF) mitigating technologies (also not required by the Organic industry standard or any other standard). We have proudly pioneered, and continue to uphold and further develop, the highest standards for product purity in the industry.

Our production facility is free of GMOs, pesticides, animal- sourced ingredients, irradiation, fillers, flow agents, and excipients. All cleaning chemicals are the most eco friendly available. The facility is part of a non chemical organic compliant active pest management program.

Furthermore, all our labels and marketing materials are printed on 100% post-consumer recycled paper, and all packaging materials are fully reusable and/or recyclable.

Sincerely,

The Excelsior Team

Compliance Report

  1. Excelsior Alchemy Follows CGMP – CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Excelsior Alchemy specifically follows CFR 21 Part 111: Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements that requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
  2. Quality processes to ensure identity, purity, strength, and composition. The CGMP rule defines “quality” to mean “that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.“
  3. NSF Registered, Listed and Audited: NSF audits the facility twice a year to make sure it is fully compliant with the FDA CFR 111 Current Good Manufacturing Practices in manufacturing, packaging, labeling, or holding operations for dietary supplements. See our certificate here and our listing here.
  4. FDA Registered and Audited. Excelsior is a registered food facility with the FDA. Our last audit in 2016 resulted in no observations.
  5. Vendor Qualification Program. All vendor ingredients must go through our Vendor Qualification program. This starts with a comprehensive questionaire. Following this we require 3 material samples that are tested to ensure they comply with the supplier Certificate of analysis to ensure identity, purity, strength, and composition and limits on contaminants. This testing includes microbiologial, heavy metals, identity (by HPTLC, FTIR with support from Authentechnologies), and component and solvents as required.
  6. Standards Operating Procedures and Forms: All facility processes are controlled by Standard Operating Procedures and Forms to ensure Good Documentation Practices.
  7. GMP Training Program: All employees are trained annually in Good Manufacturing Practices and Good Documentation Practices per our company policies to ensure safe, and sanitary work environment and quality finished products. Employees are also trained on specific job duties as required. Trainings are recorded to ensure compliance.
  8. Component Receiving. All raw materials and components (bottles, lids, seals, oxygen absorbers, labels) are processed through our receiving department. Lot numbers are assigned and samples processed by the quality department.
  9. Raw Material Testing. All raw materials that enter the facility are tested for microbiology, heavy metals, and identity before being released
  10. Batch Records: All documentation is strictly controlled throughout the process. All batches are assigned lot numbers and ingredients weighed and listed by lot number for tracking. Quality Control steps and verification processes throughout the process that include: Weigh Up, Blending, Encapsulation, Powder Fill, and Final Packaging.
  11. In Process Testing: All in process blends are tested for microbiology before being released to ensure no contamination during processing.
  12. Finished Product Testing: All finished products are tested for microbiology, heavy metals, and identity before being released.
  13. In House Laboratory: We have an in house lab that includes: High Performance Thin Layer Cromatography (HP-TLC), Fourier Transform InfraRed (FTIR), Microbiology, Scale Calibrations and ATP swab testing.
  14. 3rd Party Qualified Labs: For labs to be used by Excelsior Alchemy they must first be qualified through our audit process. Testing performed by 3rd party labs includes: Heavy Metals, Solvents, Nutritional/ Supplement Panel Testing, Component Testing, and Stability Testing.
  15. Stability Program: Finished product expiration dates are verified through our stability program by using data from retention samples and 3rd party accelerated testing.
  16. Sanitation: At Excelsior we take sanitation seriously. We have a detailed sanitation program with records and verification. Daily cleaning, daily quality control checks, deep cleaning, and 3rd party cleaning support. All equipment is sanitized before use and verified sanitary by ATP (Adenosine Triphosphate) swabs and allergen swabs
  17. Calibrations and Checks: All instrumentation from lab equipment is on an annual calibration program. Daily scale and equipment checks are performed and recorded.
  18. Allergen Program: As soy is used in the facility (soy lecithin and miso) we follow an allergen control program to avoid cross contamination.
  19. Preventative Maintenance Program: All equipment for manufacture, dust control systems, air filtration are part of our preventative maintenance program.
  20. Hazard Control – Sifting, magnets, and metal detection are used in various steps throughout the facility to insure safe, contamination free products.
  21. Sample Retention: Retention samples of all finished products are held for 1-year beyond expiration date.
  22. Specifications: All ingredients, finished product, and packaging components have quality set specifications to ensure they match the customer requirements and highest standards of quality.
  23. Ecological Concerns: All chemicals used in the facility are safe for the users and the environment.
  24. Organic Compliant Pest Control Program: This Integrated Pest Management (IPM) techniques, with a focus on inspection and removal of pest-friendly environments, eliminating food and harborage areas avoid the need for chemicals and glue traps so are animal friendly.