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Category: Tips And Tricks

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

Getting more from your oxygen business

September 12, 2013 by Jim Christ

Jim Christ travels the nation, installing transfilling systems, training providers and has just about seen it all in his 10 years of experience. Heres some of his most popular tips for getting the most from your oxygen business. Formula for success Have a consistent approach in the structure and operation of your drug manufacturing facility. Having policies and procedures that all applicable employees can understand is essential when transfilling. All employees should be trained to follow these procedures and understand what is expected of them. Setting up a consistent company structure can fortify the expectations that go along with being a drug manufacturer. First steps Dont just assume that everyone is doing everything they are supposed to do. Regulatory bodies dont. Have systems in place to double check that all of the requirements are being met when it comes to drug manufacture. Perform regular audits of your procedures, staff, and records or have an outside agency do it

Posted in Transfilling, System, Tips And Tricks, Better Oxygen Business

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