Biomedical Engineering Reference
In-Depth Information
Take two possible topics for continuing cGMP training,
one topic of a higher level of quality risk and another topic
of a lower level of quality risk. Suppose the choice was to be
made between an episode in a higher risk activity such as
aseptic processing and an episode in a lower risk activity
such as secondary packaging:
(a) The decision maker(s) should consider the two processes
and track and trend relevant deviations, out-of-spec
fi ndings, and investigations.
(b) Also, the decision maker should consider the
transferability and relevance of each process for the
specifi c training audience. In light of these three factors:
risk, transferability, and relevance, the decision maker
should estimate the potential training payoff.
(c) Finally, the decision maker should prioritize the episodes
in terms of the highest payoff to the organization, and
the highest priority example would be highlighted in the
training.
The International Conference on Harmonisation (ICH)
expressed it well: “. . . the level of effort [. . .] of the quality
risk management process should be commensurate with the
level of risk.”
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And this level of effort includes training about
the topics of the quality risk management process. Both
kinds of risk assessment, business and quality, must be taken
into account for continuing cGMP training.
7.2 Regulations call for continuing
cGMP training
FDA regulations call for continuing cGMP training. The
regulations for fi nished pharmaceuticals are quite explicit:
