21 C.F.R. § 58.107

Current through September 30, 2024

Section 58.107 - Test and control article handling

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.

21 C.F.R. § 58.107