Month: October 2013
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.
WRITTEN PROCEDURES Section 211.100(a b) All firms are expected to establish and follow detailed written procedures covering all aspects of their operation to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. These written procedures, including any changes, are to be reviewed, signed, dated, and approved by the firms quality control unit. In addition, it does little good to enact new procedures and controls if they are not read, understood, and followed by all employees, and readily available. There cannot be different standards of quality of drug products for large and small manufacturers. Written procedures regardless of the size or complexity of the operation must be established. They provide a basis for the uniform performance of a function, and they provide a step-by-step description on how to perform a specific task, function, or operation. Applied has policy and procedure manuals for gas to gas, liquid
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