Product Recalls Due to OOS Results

GMP News No. 643

GMP News
25 November 2005

Product Recalls Due to OOS Results

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?).

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.
Dr Günter Brendelberger

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