When
it comes to being prepared for an inspection from a regulatory authority, the
combination of practice and preparation will often make the difference between
success and failure.
Pharmaceutical
Manufacturing are hosting a useful article by Joachim del Boca on regulatory
inspections.
Here
is an extract:
“Regulatory
agencies are increasing their vigilance on the (bio-)pharmaceutical industry
with greater scrutiny placed upon aseptic manufacturing facilities. Perhaps one
of the most significant changes in this attentiveness has been in the area of
data integrity. A recent increase in the number of incidents where a company’s
data was falsified or poorly documented has led to new regulations.”
Posted by Dr. Tim Sandle
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Pharmaceutical Microbiology