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.
In order to facilitate the determination of the level and type of label verification required, the risks to the labeling operation should be evaluated. Then the level and type of verification for the labeling operation can be more effectively determined by technical experts and documented for compliance with the regulations. This type of evaluation and documentation is especially important with the recent incorporation of risk management into facility inspections of medical products by the FDA.
--By Linda McBride, registered pharmacist
Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in Pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
