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Supplement safety at DermaHarmony

DermaHarmony products cost more to manufacture and are extremely unique due to our commitment to safety and quality. In addition to manufacturing nutritional supplements under Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), ISO 9001 certification and ISO 17025 accreditation, DermaHarmony is committed to the safety of the raw materials that are used in our supplements. Our rigid manufacturing criteria are designed to monitor and verify product quality throughout every step of the production process. Quality comes from the procurement of the finest raw materials available.

With the introduction of the US Bioterrorism Preparedness and Response Act of 2003, California's Proposition 65, and US FDA's 21 CFR, Part 111 for Dietary Supplements, we require all raw material suppliers to comply with the requirements outlined herein.

  1. Certificates of Analysis
    1. Raw material suppliers must supply a valid, current Certificate of Analysis for each lot of raw material of every shipment, with no exceptions.
    2. If a valid Certificate of Analysis is not provided at the time of reception, the raw material are immediately refused and returned to the Supplier.
    3. An example Certificate of Analysis must be submitted for to our manufacturer for approval.
    4. Initially, three consecutive lot numbers of each raw material purchased must be tested by a third party laboratory. The results shall are provided to our manufacturer for review and approval.
    5. After initial certification as described above, a complete verification of the Supplier's Certificate of Analysis for each raw material purchased by our manufacturer during the previous year must be performed by a third party laboratory annually.
    6. The following laboratories may be utilized for the testing described above in 1d and 1e:
      1. Eurofins
      2. Chromodex
      3. Any US laboratory holding current ISO 17025:2005 Accreditation. A copy of the laboratory's valid Certificate must be provided to our manufacturer.
    7. The following criteria are required to be included on all Certificates of Analysis.
      1. Name and Address of Manufacturer.
      2. Organoleptic Evaluation - Physical Testing.
      3. Density.
      4. Particle Size Analysis.
      5. Moisture Content.
      6. Test Methodology Reference.
      7. Specifications.
      8. Actual Test Results.
      9. Microbial Limits.
      10. Impurities:
        1. Vitamins - solvent residue.
        2. Minerals - heavy metals.
        3. Herbs - pesticides and solvent residue.
        4. Amino Acids and Cartilage/Collagen - heavy metals.
      11. Numerical Results of Heavy Metal Testing.
      12. Species of Plant for products of Botanical Origin.
      13. Species of Animal for products of Animal Origin.
      14. If the raw material contains any sub ingredients, they must be listed on the Certificate of Analysis in descending order with amount and function shown.
      15. GMO (genetically modified organisms) Statement.
      16. Organic Volatile Impurities, if applicable.
      17. Suitable to be labeled as acceptable for:
        1. Vegetarians.
        2. Vegans.
        3. Kosher.
        4. Diabetics.
        5. Halaal.
      18. Allergen Information.
      19. Expiration Date:
        1. Raw Material Expiration Dates must be for at least 24 months from the date of shipment.
      20. Country of Origin.
      21. Country of Shipment
  1. Facility Certification
    1. The Supplier agrees to provide our manufacturer with audit results of their facility on an annual basis. The audit must be conducted by an approved third party auditor (a professional auditor holding current certification from NSF, ISO), or the FDA.
  1. Electronic Documentation Requirements
    1. Our manufacturer will supply an electronic specification sheet for each item. These specifications must be agreed upon prior to purchase. All specifications must be met for every lot of every item of every shipment. Any items not meeting specifications will be refused and returned to the Supplier.

How We Help

At DermaHarmony, our goals are to educate chronic skin care suffers about dermatology, share what contributes to health and wellness, and support our readers in any way we can. We manufacture and sell two soaps in our store that help with a variety of skin conditions. They're worth consideration if you have a condition that can be helped with pyrithione zinc, sulfur, or salicylic acid.

 

Principal Authors: DermaHarmony Editorial Department
Date of Initial Publication: 01/23/2007
Article Last Updated: 03/10/2011