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Introduction
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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