Biomedical Engineering Reference
In-Depth Information
criticality and complexity of the process. The next section
presents an illustrative problem that requires an investigation,
leading to the development of a CAPA plan that calls for
changes in process as well as revision of analytical laboratory
procedures.
3.4 Investigating a complex ×
critical problem
FDA-regulated industry must have a written procedure that
defi nes “events of concern,” which include actual departures
from established, approved SOPs, material specifi cations or
manufacturing orders, etc. as well as potential departures
(e.g., in the form of trends observed in a product-monitoring
system). Regulated industry must also have a procedure for
the conduct of investigations of such departures, insofar as
they actually or potentially impact the quality attributes of
the product.
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These procedures were followed regarding the illustrative
problem presented in the following example.
3.4.1 An illustrative problem
A QC staff member reported an increasing variability in the
determination of potency of the active drug of a
pharmaceutical product, a commercially available FDA-
approved tablet. The variability of data on product potency
did not fail specifi cations and was not suffi cient to cause
risk to patients taking the drug. However, the variability
was not consistent with manufacturing data from similar
products and/or processes in the same facility. Tracking and
trending suggested the increasing variability should be dealt
