USP Good Manufacturing Practices GMP Nutritional Supplements Potency Testing

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30 Steps to the Birth of a Quality Supplement

Product Development Phase

1. Concept - ongoing research constantly reveals exciting new nutritional ingredients and combinations.

2. Scientific Review - and his research team review the medical, clinical, and scientific literature to verify the safety and establish the ideal dosage for each new nutrient.

3. Compatibility Study - Each new supplement is designed to be taken safely with every other our nutritional products.

4. Search for Ingredients - we import ingredients from 23 different countries around the world.

5. Vendor Audit - Prospective raw material suppliers are visited and inspected to ensure their conformance with Good Manufacturing Practices (GMP), equitable labor policies, and environmental responsibility.

6. Raw Materials Specifications - All incoming ingredients conform to pharmaceutical standards of purity and effectiveness and meet or exceed the strict Federal requirements of the Dietary Supplement Health and Education Act (DSHEA).

7. Ingredient Testing Methods - Our analytical laboratory works with scientists around the world to develop unique and reliable methods to guarantee the identity and potency of the ingredients in every one of our supplement.

8. Master Formula - Each supplement is produced from a precise Master Formula, which specifies ingredients, equipment, detailed manufacturing instructions, and even climate conditions.

9. Pilot-Scale Blend Study - Pilot studies enable our scientists and technicians to optimize each Master Formula. Pilot-scale blenders are simply scaled-down models of full-scale production equipment. A pilot batch of ingredients is blended to determine the ideal mixing time and conditions that will ensure a uniform product.

10. Pilot-Scale Dosage-Form Study - The pilot blend of ingredients is then converted into the appropriate dosage form (tablet, capsule, liquid, powder, etc.), so that strict tolerances can be set in the Master Formula for the finished product.

11. Approval for Full-Scale Production - Upon passing an exhaustive battery of tests, the Master Formula is approved and a requisition is issued for full-scale production.

Production Phase

12. Receipt of Incoming Raw Materials - No ingredient is received at our manufacturing facility unless it is in properly labeled packaging with tamper-evident seals. All incoming shipments must be accompanied by full documentation, including independent Certificate of Laboratory Analysis.

13. Identification Screening of Raw Materials - Our Quality Control inspectors employ advanced n-IR (near infrared) scanning probes, which send a high-intensity beam of energy though the sealed containers. As no two ingredients will absorb n-IR energy in the same way, a unique fingerprint can be determined for each ingredient.

14. Quarantine and Release of Raw Materials - Once positively identified, all incoming ingredients are segregated and thoroughly lab-tested, including tests for biological pathogens. Upon completion of successful testing, the ingredients are released for use in production.

15. Full-Scale Production - All products are produced under climate-controlled conditions in FDA-inspected facilities operating under Federal Good Manufacturing Practices (GMPs).

16. Weighing and Blending - Following the Master Formula, each ingredient is weighed, tagged, and placed in a separate container from each other ingredient. As each ingredient is weighed, both the operator and supervisor must sign off on the master batch record. This double signoff is repeated again when each ingredient is added to the blender. As a final step, the tags from each ingredient are tallied to eliminate any possibility of error.

17. Weight Variation Analysis - In-process, tablets and capsules are spot-weighed every ten minutes by quality control technicians to certify that all products are of uniform weight for consistent dosage.

18. Size Variation Analysis - Pharmaceutical micrometer gauges verify that all tablets and capsules conform to specifications. These special gauges are accurate to 5/1000 of an inch.

19. Tablet Coating - Finished tablets are glazed with our proprietary VitaCoat™ for ease in swallowing and to ensure freshness. VitaCoat™ uses the antioxidant power of alpha-lipoic acid to help protect the tablet against oxidation and loss of potency.

Product Testing Phase

20. Potency Analysis - Potencies of all supplements are confirmed by rigorous analysis, using sophisticated laboratory equipment such as High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectroscopy (FT-IR), Ultraviolet/Visible Light Spectrometry (UV/VIS), and Inductively-Coupled Plasma Emission Spectroscopy (ICP).

21. Content Uniformity Analysis - At several points of the production run, samples are taken and analyzed to make sure that they contain the same levels of active ingredients.

22. Microbiological Analysis - Ingredients and finished products alike are tested to confirm the absence of harmful bacteria, yeast, and mold. This attests to the cleanliness and sanitation of plant, equipment, and ingredients.

23. Tablet Hardness Analysis - Tablet hardness analysis guarantees that the tablet will not fall apart in normal shipping and storage.

24. Friability Testing - Friability testing ensures that the tablet will not fray at the edges, which would cause loss of potency.

25. Disintegration Testing - we guarantee that every tablet will disintegrate under conditions found in the human body. We confirm this by testing to strict governmental USP standards.

26. Dissolution Testing - It is not enough for tablets to disintegrate (fall apart). They must also dissolve in order to be absorbed and utilized by the body.

27. Packaging Materials Barrier Testing - Bottles are specially designed to be impervious to air and water vapor, which can degrade delicate active ingredients.

28. Packaging - Bottles are filled on modern, high-speed, fully-automated packaging lines. Safety seals are affixed both inside and outside each bottle.

29. Product Stability Testing - To guarantee stability, all products are subjected to rigorous challenge testing. Random production samples are placed in specially designed chambers, where they are submitted to temperatures of almost 100° F and relative humidity of 75% for 12 weeks. They are then subjected to an exhaustive battery of tests.

Total Quality Management

30. Total Quality Management - we stand committed to continued improvement of its quality products. To that end, our manufacturing operation has instituted an on-going system of GMP training and Standard Operating Procedure review. Our Quality Assurance program even calls for internal audits, to make certain that we are living up to the high standards written into our policy.

 

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