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Category: SOP

Do you have written procedures? (SOP, Policy and Procedure Manual)

October 24, 2013 by Kristen Cifranic

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

Posted in SOP, CGMP, Tips And Tricks, FDA

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