Packaging and Labeling
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Once the finished dosage form is made, this department puts it into the primary container and labels it. Additional packaging (e.g., shipping boxes) and labeling (e.g., package inserts) are also included. Because of the many products and labeling materials, personnel in this area must be alert to prevent mix-ups.
Example of a GMP expectation that applies to Packaging and Labeling
Controls and in-process checks are carried out throughout the packaging/labeling operation to ensure proper labeling.
Example of GMP requirements specific to this GMP expectation
U.S.
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There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features: (a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products.
Canada
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Packaging operations are performed according to comprehensive and detailed written operating procedures or specifications, which include the identification of equipment and packaging lines used to package the drug, the adequate separation and if necessary, the dedication of packaging lines packaging different drugs and disposal procedures for unused printed packaging materials. Packaging orders are individually numbered. [C.02.011 # 29]
European Union
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There should be formally authorized Packaging Instructions for each product, pack size and type. These should normally include . . . in-process controls with instructions for sampling and acceptance limits. [EU # 4.16(h)]
