21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies

§ 58.47 Facilities for handling test and control articles

Subpart C - Facilities Official text on eCFR Amendment history

(a) As necessary to prevent contamination or mixups, there shall be separate areas for:

(1) Receipt and storage of the test and control articles.

(2) Mixing of the test and control articles with a carrier, e.g., feed.

(3) Storage of the test and control article mixtures.

(b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures.

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Amendment history

Federal Register documents that created or amended this section.