Biomedical Engineering Reference
In-Depth Information
after which the completed project is fully documented, and
fi nal approval is sought.
An experimental study was conducted to evaluate the
effects of the facility changes, revised calibration procedure,
and revised weighing procedure. The same procedure as
previously used to evaluate and characterize the balance
prior to changes was used. The balance was recalibrated
using the new calibration procedure. Multiple weighings of
typical standard weights at the lower calibration limit of the
balance were performed according to the revised weighing
procedure. All weighings were again documented in
controlled laboratory notebooks including witnessing and
verifi cation by trained laboratory personnel. Mean and
standard deviation were calculated. Expectations were that
results would be statistically equivalent or improved,
relative to pre-change results. Results indicated equivalent
accuracy and lower variation as refl ected in lower standard
deviations.
All the changes were initiated for routine use in support of
commercial manufacturing. The responsible project manager
developed a document describing all associated changes
(Table 3.6).
When the change management document was completed,
it was affi xed to the procedure change documentation as
supporting evidence for the change. Implementation of the
change required management approval, SME approval, and
supporting experimental data.
3.5 Conclusion
This chapter addressed changes to process as well as the
revision of SOPs. In order to ensure that the revision of the
SOP adds value, it should be subjected to critical review. A
