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To provide written instructions for collecting and holding reserve samples for each lot of packaged and labeled dietary supplements that we distribute.
All Warehouse employees (either internal or contract - e.g., 3rd party) that manage returned dietary supplements are responsible for following this SOP. Quality Control is responsible for following this SOP and being aware of the following documentation:
For each lot of packaged and labeled dietary supplements received for distribution, four units (e.g., months supply) will be retained as reserve samples. Example: For Vitality keep 4 capsules x 30 days x 2 boxes = 240 capsules worth in two containersThese reserve samples will:Be held in the designated area using the same container-closure system in which the packaged and labeled dietary supplements are distributed. Be identified with the batch, lot, or control number. Be retained for one year past the shelf life (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations. Consist of at for all tests or examinations to determine whether or not the dietary supplement meets product specifications. Be held in a manner that protects against contamination and deterioration. This will be accomplished by:Holding the reserve samples under conditions consistent with product labels or, if no storage conditions are recommended on the label, under ordinary storage conditions.Ordinary storage conditions in our warehouse are considered to be approximately 68-76 degrees Fahrenheit. Reserve samples that have been held for the aforementioned length of time required will be reviewed by Quality Control, who will decide to do the following:Conduct analytical testing on the reserve samples to evaluate product shelf life and stability. Continue to hold the reserve samples to either destroy or conduct analytical testing at a later date.
PURPOSE
RESPONSIBILITY
PROCEDURES
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