GMP News
25 November 2005
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Product Recalls Due to OOS
Results
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During an inspection of a US-American generics manufacturer, inappropriate
OOS handling was the main point of criticism noted on a 483 form. The
inspectors complained among others about the following points:
- OOS results were not reported
- There were no records on the OOS results in the laboratory
notebooks, nor were there any laboratory investigations concerning the
OOS results
- OOS results were replaced by acceptable results that were obtained
through "cutting and pasting" of chromatograms, the exchange of
vials, the modification of the sample weight, or selecting a different
method
- The personnel had not been trained in the existing OOS SOPs
- The number of re-tests laid down in the OOS SOP was not observed
- The QC Unit released batches that did not comply with the finished
product specifications and stability specifications
- OOS results were not mentioned in the annual reports for ANDAs
addressed to the FDA
- The Field Alerts that would have been necessary for those products
not complying with the specifications were not filed
- There was no appropriate failure investigation for the deviating
products
The complete 483 form including a great number of examples can be found
here. The inspected
company published the 483 form on its own website (maybe it had to?).
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You will receive detailed information about the GMP-/FDA-compliant
investigation and documentation of Out-of-Specification Results at the ECA
Education Course Out-of-Specification-Results
to be held in Vienna, Austria, on 27-28 March 2006. At this course the
most important and most recent issues of the expected PDA Technical Report
about OOS Results will be presented by Dr. Chris Burgess, who is a member
of the PDA OOS Task Force. In the subsequent Post-Course Workshop on
Failure Investigation, QC and QA professionals will learn how to conduct
Failure Investigations by using real-case studies.
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Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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