As seenin the Warning Letter Report issued by the European Compliance Academy (ECA) observations in "Production Record Review" (21 CFR §211.192) are among the most frequent GMP deviations cited by the U.S. Food & Drug Administration (FDA). As in previous years, more Production Record Review deviations than others were again determined in 2009.
When taking a closer look at observations on 21 CFR §211.192 it becomes apparent that most complaints correspond to the handling of deviations and failure in CAPA. While in most cases the deviations were noted by the companies , they were not thoroughly investigated and no corrective and preventive actions were determined.
A comparable scenario also emerges with medical products, where Warning Letters on 21 CFR §820.100: "Corrective and preventive Action" always list the most observations.
Current developments as the Quality System Guide, ICH Q10 recently published by the FDA, the new draft for chapter 1 of the EC-GMP guideline and precisely these excerpts from the Warning Letters show the importance of correctly handling deviations and a respective CAPA system.
On behalf of ECA