McGuff Company News Room
McGuff Designs, Builds and Validates New Refrigeration Capacity to cGMP Requirements
February 11, 2008
The McGuff Company, in anticipation of continued record demand for Ascor L 500 (Ascorbic Acid for Injection) Ascor L NC (Ascorbic Acid for Injection, Non-Corn) refrigerated injections, has contracted to build additional refrigeration capacity at its Corporate Headquarters, Santa Ana, California. The new refrigeration unit will be 6.6 times greater in capacity than the unit it replaces.
McGuff Pharmaceuticals, Inc., a Food and Drug Administration (FDA) inspected sterile fill manufacturer, produces all Ascorbic Acid for Injections that are sold by the McGuff Company.
In addition to injectable drugs, the refrigeration unit is designed to provide immediate access to study drugs used in Investigational New Drug clinical trials.
The refrigeration units design and build out assure compliance to the Current Good Manufacturing Practices (cGMP) required of all FDA reviewed manufacturers and distributors.
Many dangerous drugs come with a requirement that they be kept in a cold environment. The United States Pharmacopeia XXXI (USP) states "Cold-Any temperature not exceeding 8 degrees Celsius (C) (46 degrees Fahrenheit (F)). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees C (36 and 46 degrees F)."
The McGuff Company assures the integrity of refrigerated products by utilizing a temperature chart recorder capable of recording temperatures within the refrigeration range to plus or minus two percent accuracy. Additionally, the McGuff Company records the mean kinetic temperature of its warehouse to assure conformity with the USP XXXI requirements for dangerous drug and device storage at controlled room temperature.
The McGuff Company takes pride in its ability to provide customers with products that have been stored in compliance with the USP and cGMP requirements.
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