20 Questions On MHRA Website) : OOS Presentation
20 Questions On MHRA Website) : OOS Presentation
Your firm has not thoroughly investigated the failure of a batch or any of its components to
meet its specifications whether or not the batch has already been distributed, and you failed to
extend the investigation to other batches of the same drug product that may have been associated
with the specific failure or discrepancy.
Your firm's out-of-specification (OOS) investigations did not include analysis of all available
data.
Inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its
specifications or quality standards.
Your firm has failed to conduct an investigation for numerous OOS results (e.g., for colony
forming units, conductivity, assay, etc.). Many of these OOS results were not reported to your client.
Your QCU approved and released a batch of … despite an initial OOS bulk assay result.
These results were later confirmed through repeat testing, but further testing of additional samples
produced passing results. Your QCU released the batch even though the investigation did not
identify a discernable cause.
Your QCU failed to detect multiple discrepancies in sample weights and dilution factors
between the analyst's notebook and the Calculation Sheet. As a result, incorrect data was recorded
for multiple products and finished products not meeting specifications were released. Specifically, a
lot of … was released and distributed even though it did not meet the established specification of …
% label claim. The correct calculation would have reported a … % label claim.
Your QCU did not require a second, independent person to review the raw data, calculations
and records before releasing these lots for distribution.
The inspection also found that your analyst did not record these out-of specification results in
the OOS logbook as required by your SOP.
Your investigation failed to follow your procedures when your firm … initiated Phase 2
sample testing prior to completing Phase 1 of the investigation, and … only analyzed two samples
as opposed to the required three samples.
In order to assist the pharmaceutical industry in a FDA/GMP-compliant handling of OOS Results, the
ECA Quality Control Working Group has established a general SOP for the handling of OOS results.
Version 01 of this OOS SOP has been finalized in the meantime and will be presented at ECA's
OOS Forum, from 19-20 June 2012 in Prague, Czech Republic. (OOS forum)