Test, control, and reference substance handling.

Procedures shall be established for a system for the handling of the test, control, and reference substances to ensure that: (a) There is proper storage. (b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage. (c) Proper identification is maintained throughout the distribution process. (d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.