Procedures shall be established for a system for the handling of the test and control articles 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.