From
a more global point of view, the goal of failure mode effects analysis (FMEA)
for filter integrity testing (FIT) is to align the risks as closely as possible
with its source. This analysis can identify the root cause of the risk and help
the quality assurance staff and operators detect the occurrence of a particular
deviation. Additionally, the analysis also helps define the adapted level of
training to reduce operator mistakes.
Magnus
Stering has written an interesting article for Pharmaceutical Processing about
the risk assessment of filter testing.
The
article identifies risks for achieving a higher level of FMEA for FIT and for
improved quality assurance. It can be
accessed here.
Posted by Dr. Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources