Temperature-sensitive pallet shippers
According to the regulations enforced by the Food and Drug Administration, "There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products" (21 CFR 211.130) and "Each manufacturer shall control labeling and packaging operations to prevent labeling mixups" (21 CFR820.120d). Verification of the correct labels can be simple or complex. A labeling process that utilizes preprinted labels affixed during the packaging process may require a simple verification. A more complex verification may be required for a process such as the downloading of product information from an ERP system for the on-line printing of unit labels and cartons that could include printing, reading, and verifying bar codes.
Nov 10, 2005
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FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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