Biomedical Engineering Reference
In-Depth Information
A rationale for continuing cGMP training is provided in
several guidances. For example, the
Quality Systems
Approach to Pharmaceutical cGMP Regulations
indicates
that “continued training is critical to ensure that the
employees remain profi cient in their operational functions
and in their understanding of cGMP regulations.”
10
Likewise,
the ICH states, “Training should be regularly conducted by
qualifi ed individuals and should cover, at a minimum, the
particular operations that the employee performs and GMP
as it relates to the employee's functions.”
11
The usefulness of continuing training has been observed
outside the area of GMPs. Continuing training in good
clinical practices (GCPs), for example, has been recommended
for clinical trials staff, as well as for Institutional Review
Board (IRB) members.
12
Hence the FDA regulations provide a mandate for
continuing cGMP training. Of course there are interpretive
issues regarding these, as any, regulations. As Michael Breggar
has correctly put it, “most drug regulations are subject to
interpretation.”
13
Organizations in the life sciences do not
simply react to a regulation; instead there is an intricate
interaction between organizational actors at all levels and the
various regulations and regulatory regimes, all within a given
organizational setting.
14
Between an observation of a gap and
an organization's response is a complex decision process. This
will occur whether the gap represents a higher level of risk,
such as the level of viable particulates in a monitored area, or
a lower level of risk, such as one, ten, or a hundred employees
failing to attend the annual cGMP refresher training. As
already noted, an observation is typically escalated, triaged,
and may or may not become a record of interest in the
organization's quality management system. Whether the
observation will or will not become a record of interest
depends upon the risk assessment. It is that record that may
