In our
GMP news from
30 November 2006 we reported about the comprehensive study the FDA had commissioned in
2002. This study analyses confidential FDA internal data on GMP
inspections and deviations from 42 pharmaceutical, API and biotech
companies.
The study's most important results are introduced in a 45 minute
presentation by the two authors and FDA Co-Principal Investigators
Jeffrey T. Macher and Jackson A. Nickerson. The presentation's core is a
static model intended to make the following predictions:
- Probability of a production facility being chosen for a FDA
inspection
- The effect of education, experience and individual effects on
the inspection findings
- Characteristics of a production facility correlating with the
probability of GMP deviations
The presentation is a must for everybody working in the area of GMP
compliance, and especially for those in FDA regulated compliance.
To start the presentation, go to the following link. As for ECA
webinars, you will need a PC with speakers:
http://www.olin.wustl.edu/faculty/nickerson/results/FDATest1_files/Default.htm
Prepared by:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)
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