The strictest quality control is maintained. Independent laboratories analyze each new CMO raw material lot. In all stages of blending, encapsulating and bottling, batch logs are recorded. The inspector of the run must sign these batch logs. Should an error be detected, all products since the last check are removed, destroyed or reprocessed. Each bottle of CMO is checked several times. Content, quality and fill weights are checked at several different points during the manufacturing process. Our Certificate of Analysis is derived from the laboratory test and batch records.

• Weighing: The weighing of each ingredient is checked by at least two workers who must each initial the manufacturing batch record.

• Mixing: Depending on the size of the batch, the powders are transferred to a ribbon blender or a drum mixer that was inspected first. The mixing time is strictly controlled according to manufacturing instructions and must be entered into the manufacturing batch book.

• Filling: The resulting mix is transferred to a semiautomatic encapsulation machine. At predetermined times during the filling process, samples of the capsules are evaluated for proper weight of mix. If it is determined that any problem exists, all capsules filled since the previous check are destroyed.

• Bottling: The filled capsules are placed in a semi-automatic bottling machine, which dispenses the proper amount of capsules into each bottle.

• Labeling: A semi-automatic labeling machine is used to apply supplied labels and print batch numbers and expiration dates or a separate batch number.