International collaboration
November 2, 2011
THE final report on the
International Active Pharmaceutical
Ingredients Inspection Pilot
Program has been released, and
highlights improved cooperation
and confidence between the
Therapeutic Goods Administration,
the US Food and Drug Authority
and the European Medicines Agency.
The program took place over 24
months, ending in December last
year, and was designed to enhance
information sharing and
cooperation on the inspection of
manufacturing plants producing
active pharmaceutical ingredients.
As part of the program a “master
list” was developed which included
information on manufacturing
sites (name, address, products
made, last inspection date and
outcome, planned inspection date)
provided by each participant.
Feedback forms were also
developed for inspectors in order
to identify possible differences
between an inspection done by a
national team of inspectors and an
inspection done by an
international team.
According to the TGA, following
the improved information sharing
between the regulators it is now
able to better determine where to
place its audit efforts, whilst the
alignment of audit schedules now
means that regulators are able to
avoid duplicated effort and better
target resources, at the same time
as reducing unnecessary burden
on manufacturers.
The TGA’s access to audit reports
from other regulators also now
allows it to be better prepared when
audits are deemed necessary.
“The TGA will continue to work
with the program partners to
refine and enhance the outcomes
of the pilot, to identify better ways
of collating and sharing
information and to identify other
opportunities to enhance its
clearance program for overseas
manufacturers,” the TGA said.
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