Your 1 Minute Guide to the Maintenance and Storage of Drug Labeling and Packaging – 21 CFR Part 211.22(c-d) [Video]

Section 211.122 states the following with regard to maintenance and storage of drug labeling and packaging:

Maintained for Each Shipment

(c) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination or testing, and whether accepted or rejected.

Stored Separately

(d) Labels and other labeling materials for each different drug product, strength, dosage form, or quantity of contents shall be stored separately with suitable identification. Access to the storage area shall be limited to authorized personnel.

Obsolete and Outdated

(e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed.

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP