Biomedical Engineering Reference
In-Depth Information
This illustrative account could be proposed to the training
council or other appropriate group and, if approved, could
be worked up into a continuing cGMP training module. It
would be of interest to the organization's staff, because it
refers to their warehouse, they may know the form in
question, they may know some of the employees who were
involved in the problem, and they will be pleased to see the
satisfactory outcome of the investigation.
Perhaps the best approach to sources of topics for continuing
cGMP training is a combination of local problems gleaned
from records in the organization's quality management
system, with direction provided by the most serious
compliance problems, as indicated by FDA warning letters
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(Table 7.3). For instance, one recurring topic from fi scal years
2005 through 2008 has been 21 CFR 211.22, “Responsibilities
of Quality Control Unit.” Should the organization's records
Most serious GMP problems in FDA warning
letters, FY 2008
Table 7.3
Regulation
Topic
§211.192
Production record review
§211.160
Laboratory controls
§211.100
Written procedures; deviations
§211.22
Responsibilities of quality control unit
§211.42
Design and construction features
§211.84
Testing and approval or rejection of components,
containers, and closures
§211.110
Sampling and testing of in-process materials and
drug products
§211.113
Control of microbiological contamination
§211.165
Testing and release for distribution
§211.188
Batch production and control records
