21 CFR § 58.107 Good Laboratory Practice for Nonclinical Laboratory Studies

§ 58.107 Test and control article handling.

Current through Sep 8, 2026 · Read all of Part 58

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.

← § 58.105 Test and control article characterization.§ 58.113 Mixtures of articles with carriers. →