Biomedical Engineering Reference
In-Depth Information
do not add value are wasteful, and from a regulatory
standpoint suggest that a process is not in control. In order
to ensure that the revision is appropriate, the SOP should be
subjected to critical review. Newly written procedures can
also be subjected to critical review.
Approaches to the critical review of procedures vary in
terms of increasing credibility of the review fi ndings. It is a
prerogative of management to weigh the benefi ts of increasing
credibility against the costs of increasing rigor of the
approach. This cost/benefi t analysis must be informed by a
determination of the degree of change that is involved in the
revision, as well as a risk assessment of the change.
After examining the critical review of SOPs, this chapter
will consider how the management of change depends upon
risk assessment. It has three components: risk identifi cation,
risk analysis, and risk evaluation. The criticality and
complexity of the process tends to increase the level of risk.
And the appropriate level of critical review and effort
supporting implementation of change is directly related to
the criticality and complexity of the process.
Following the discussion of risk, an illustrative problem is
presented. Over time, the variability of the potency of an
active pharmaceutical ingredient (API) was seen to increase.
This is a complex problem, implicating the weighing facility
and instruments for the analytical standard, as well as the
associated weighing procedure and calibration procedure. It
is also clearly a critical problem, as the potency of the API
impacts the quality attributes of the product.
A CAPA plan is developed and implemented to remediate
the facility and instruments; this leads to revisions to the
relevant SOPs. It is necessary to review critically the adequacy
of these revised procedures. The CAPAs are tested, and the
results lead to informed decision making about the changes
as well as mitigation of the original problem.
