Manufacturing Policies

To ensure the quality of our products, the following is applicable during the steps in the manufacturing processes:

1. Raw materials (including capsules) are only ordered from reputable firms that are Good Manufacturing Practices (GMP) compliant. All materials are shipped in poly-lined cartons or barrels.
2. All raw materials entering the manufacturing facility are quarantined pending the following:
   1. Physical damage inspection
   2. Packing slip/quantity/product ID verification
   3. Product visual check for impurities or visible contaminants
   4. Product color/taste/odor/texture check and verification against Certificate of Analysis
   5. Archive sample is taken and attached to Certificate of Analysis for filing and mirror sample is taken for analysis for bacterial contaminants.
   6. Once all state is confirmed as accurate, product is released for use.
3. Raw materials are then shelved in the warehouse where they are pulled for use on a "first in-first out" basis.
4. Each time a raw material is pulled for mixing, Steps 2A and 2C are repeated as product is extracted from storage container.
5. Ingredients are weighed individually, and weight and lot numbers are recorded.
6. Entire mix is then checked for overall weight against expected total and also recorded.
7. Product is then mixed, milled (80-mesh) if necessary, and undergoes visual and texture checks prior to and throughout the encapsulation process.
8. Weight checks on capsules are performed at least every 15 minutes throughout encapsulation to ensure consistency within acceptable weight tolerances.
9. When encapsulation is complete, entire mix is reweighed, random capsules are test-weighed, and calculations are performed to ensure entire mix capsule count is within acceptable tolerances.
10. Capsules are then polished to remove dust, run through a metal detector, and sealed in poly-lined barrels to be staged for packaging.
11. ID tags are attached to all staged products in all staged containers throughout entire portioning/mix/encapsulation process from initial portioning through the packaging process to avoid cross-contamination with other ingredients or products.
12. When capsules reach packaging, they remain staged in poly-lined barrels until the entire batch is placed in specified containers for shipping.
13. Bottling, cottoning, capping, sealing, and labeling are performed on an automated line. This line is designed to ensure no outside contaminants enter the bottles when capsules are being bottled.
14. Quality assurance checks are made throughout all packaging steps to ensure the product, count, container, label, and shipping carton are consistent with the specifications of the batch.
15. Key steps in all processes listed above are confirmed by management "check-off" throughout all process steps to ensure quality.