How To Avoid FDA 483s For Temperature, Humidity And Other Controlled EnvironmentsSource: Vaisala, Inc.
The following article shows three excerpts from some of the more common “observations” noted in Form 483 Letters. (The names have been left out in this application note, but are a matter of public record). Each of these deviations involved environmental conditions (temperature, humidity, etc.) in a variety of GxP settings; they range from failure to properly validate containers for Human Cell & Tissue Products to a lack of temperature records in an aseptic processing area of a drug manufacturing facility. None of the deviations excerpted here are unique, but all are avoidable.
After the excerpts, we outline some best practices of a 483 response, providing a 10-point checklist (to make that 15-day time limit more manageable) with some links to further resources. Finally, we’ll look at ways to simplify and automate monitoring, alarming and reporting on FDA regulated environments. Options range from low-tech manual methods, to hybridized systems that combine written and electronic methods of documentation, to fully automated systems for compliance with 21 CFR Part 11 and cGMPs.