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What cGMP Requirements Apply to Equipment Used to Produce Pharmaceuticals?

March 9, 2010
Question 

How would 21 CFR 211 impact a printer that prints supplied graphics on tubing received from another company? The printer does not create the graphic content or supply the material. After the printing is completed, the printer sends the materials, in rolls, back to the first company, for tube formation and filling for a third party.

Answer 

While Title 21 of the Code of Federal Regulations (C.F.R.) Section 211 ("Current Good Manufacturing Practice for Finished Pharmaceuticals") generally applies to drug manufacturers, there are implications for suppliers. The cGMPs require drug manufacturers to have written specifications for all drug product containers, and to test each lot of containers received from suppliers for compliance with these specifications. Furthermore, section 211.22 gives the quality control unit of a drug manufacturer the authority to review the production records for all packaging materials from suppliers.

Other liability issues may also exist. However, more information—such as how the tubing is used and specifications required by the drug manufacturer—is needed to determine them. Please consult legal counsel to help determine your specific legal obligations.