FDA Drug Product Labels: PACKAGING and LABELING CONTROL Sections 211.122, 125, 130 A firm must establish written labeling procedures covering the receipt, identification, storage, handling and examination of all labeling. Procedures should cover the reconciliation, issuance, returns, and security of labeling. There must be written procedures to assure that the correct label is used on the drug product, including the identification of each batch with a lot number. All high pressure cylinders, large cryogenic vessels and cryogenic home vessels are required to bear an adequate drug product label. This label is usually the responsibility of the manufacturer, filler, transfiller, etc. There can be only one drug label on a high pressure cylinder or cryogenic vessel, and that label is usually applied by the manufacturer, filler, transfiller, etc. of the drug product. Cryogenic home vessels come from the manufacturer with a DEVICE label, which should not be confused with the required drug label.
Do you have written procedures? SOP, Policy and Procedure Manual?
Are you calibrating your analyzer as required? Oxygen analyzers are required to be calibrated each fill day with a specialty calibration gas that has a COA like our calibration gases. The FDA does not allow USP oxygen to be used to calibrate analyzers. (i.e. you cant use the oxygen you get to fill your tanks to calibrate your analyzer!) For Servomex Analyzers: Oxygen Specialty Calibration Gas, E cylinder SG-100-1 Nitrogen Specialty Calibration Gas, E cylinder SG-200 For Oxygraf Analyzers: Oxy/Air Mix Calibration Gas, E Cylinder SG-400
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