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What is
WHOPIR ?
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The World Health Organization Public Inspection Reports (WHOPIR)
is a summary of the inspection report of
- a manufacturing site for Active Pharmaceutical Ingredients (APIs);
- a manufacturing site for Finished Products (FPs);
- an organization such as a Contract Research Organization where a bioequivalence study or other clinical study had been performed (CROs);
- a quality control laboratory
The
WHOPIR reflects the inspection report and gives a summary of the observations
and findings made during the inspection, but excludes confidential proprietary
information. It indicates also the date and duration of the inspection as well
as the scope of the inspection.
After a period of three years, WHOPIRs are moved to the
section marked "Archived WHOPIRs". If a site is inspected and found
to be non-compliant with GMP after a WHOPIR was issued following a previous inspection, that WHOPIR will be
removed from the web site (as the site is then no longer considered compliant
with GMP).
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