Biomedical Engineering Reference
In-Depth Information
The scope of this training will “relate to the employee's
functions;” the objective of this training will be “to enable
that person to perform the assigned functions.”
Moreover, 21 CFR 211.25(b) goes on to say that the
supervisors of these persons shall be trained so as “to provide
assurance that the drug product has the safety, identity,
strength, quality and purity (SISPQ) that it purports or is
represented to possess.”
Three points follow from these stipulations. First,
employees must have technical (or skill) training in their
particular assignments. Second, the employees must have
training in cGMPs that constrain the exercise of skills. Third,
supervisors are responsible for the SISPQ of the drug product,
and must be trained to fulfi ll that responsibility.
13.2.1 Training, or the lack thereof
How have companies within the scope of 21 CFR 211
responded to these requirements? We have reviewed the FDA
GMP Warning Letters sent during the fi ve-year period
between January 2003 and December 2007.
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There were 25
Warning Letters that mentioned deviations regarding aspects
of 21 CFR 211 during that time period; they listed a number
of observations that the FDA investigator had made during
site visits to companies within the scope, including such
issues as cleaning, contamination, sampling, etc. Seven of
these Warning Letters (over 25%) also cited inadequacy of
training, or inadequacy of the documentation of training -
including inadequacy of skills training, training in GMPs,
and supervisory training.
This pattern is not a historical anomaly; the FDA has been
concerned about the adequacy of training in the
pharmaceutical industry for some time. For example,
regarding a somewhat earlier time period, FDA Senior
