Biomedical Engineering Reference
In-Depth Information
standard. The balance used to measure the analytical standard
was located on a laboratory bench top in a busy location of
the analytical lab. The lab was located on an upper fl oor of
the QC laboratory building. Multiple weighings of typical
standard weights at the lower calibration limit of the balance
were performed according to the approved weighing
procedure. All weighings were documented in controlled
laboratory notebooks, including witnessing and verifi cation
by trained personnel. Mean and standard deviation of
weighings were calculated. Results indicated higher than
expected variation, confi rming the initial reports from QC.
Observation of analysts performing the weighings also
suggested that the placement of the standard weight on the
balance pan affected the weight data. The weighing procedure
did not require that the sample to be weighed be placed in
the center of the balance pan.
A CAPA was developed, based on these experimental data
and associated observations, as well as the risk analysis
indicating the importance of the analytical standard weighing
process.
3.4.2 CAPA for the problem
As the ICH has stated, a “pharmaceutical company should
have a system for implementing corrective actions and
preventive actions resulting from the investigation of [. . .]
trends from process performance and product quality
monitoring.”
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Such a system came into action as a result of
the investigation into the illustrative problem presented in
this chapter. Because the variability of data had not yet failed
specifi cations, the CAPA plan highlighted the preventive
actions.
The preventive actions focused on upgrading the weighing
procedure and facility used for weighing, followed by
