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20 Questions On MHRA Website) : OOS Presentation

The document discusses guidance from regulatory agencies like the FDA and MHRA on handling out-of-specification (OOS) results during laboratory analysis. It notes that incorrect handling of OOS results continues to be an issue according to FDA warning letters in 2011. Examples of citations from these letters include failure to investigate or document OOS results, not thoroughly investigating batches that failed to meet specifications, and inadequate or lack of investigations into critical deviations. To help the industry properly handle OOS results in a FDA/GMP-compliant manner, the ECA Quality Control Working Group established a general SOP that will be presented at an upcoming OOS forum.

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1K views2 pages

20 Questions On MHRA Website) : OOS Presentation

The document discusses guidance from regulatory agencies like the FDA and MHRA on handling out-of-specification (OOS) results during laboratory analysis. It notes that incorrect handling of OOS results continues to be an issue according to FDA warning letters in 2011. Examples of citations from these letters include failure to investigate or document OOS results, not thoroughly investigating batches that failed to meet specifications, and inadequate or lack of investigations into critical deviations. To help the industry properly handle OOS results in a FDA/GMP-compliant manner, the ECA Quality Control Working Group established a general SOP that will be presented at an upcoming OOS forum.

Uploaded by

pawnammal
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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The FDA Guidance on OOS Results from 2006 is known to each analyst working in the

regulated Pharmaceutical industry. 


Guidance from the MHRA on how to handle out-of-specification results during laboratory
analysis is still unknown. 
This webpage lists 20 questions which are critical when handling OOS results. (20 Questions
on MHRA website )
There is an excellent presentation on MHRA website, to handle Out Of Specification Investigations.
(OOS presentation)

In a recent  article published by Dr Günter Brendelberger  in European Compliance Academy a


review of the 2011 FDA Warning Letters shows that the incorrect handling of OOS results is still a
hot topic in FDA inspections and inspection follow up activities (483s, etc.). In total 10 companies (6
drug product manufacturers and 4 API manufacturers) received a FDA Warning Letter relating to
OOS investigations in the calendar year 2011. The article by Dr Günter Brendelberger  gives  some
examples of these citations:

Failure to investigate and document out-of-specification results obtained for

 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)

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