Guide for US FDA-Regulated Organizations

Ken Appel

No cGMP manufacturer wants to receive a Form 483 letter (“Notice of Inspectional Observations”). In such stringently controlled industries as pharma-ceutical/biotechnical development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system. Worse, with the 2009 increase in enforcement staff1. and the September 2009 change to the response time—now 15 days—the FDA appears to be ramping up its enforcement mandate2.
The following article shows three excerpts from some of the more common “observations” noted in Form 483 Letters during 2008-2009. (The names have been left out in this article, but are a matter of public record)3. Each of these deviations involved environmental conditions (temperature, humidity, etc.) in a variety of cGMP 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’ll outline some best practices of a 483 response, providing you with a 10-point checklist that should make that 15-day time limit more manageable, and some links for further research. 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.
Sample Deviation #1
To a Contract Pharma manufacturer:
“Requirements for stability testing of drug products are not being met. For example, you do not have, as part of the storage condition, any documentation that stability samples are maintained at the designated temperature [21 CFR 211.166(a)(2)]; and you do not have appropriate stability data to support the 4 year expiration date for the product. [21 CFR 211.166(b)]”


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