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GMP News
2 April 2008

Deviations and Failure Investigation -
CAPA in the Light of FDA Inspections

As indicated by ECA's Warning Letter Report, deficiencies in the production record review are among the most frequent GMP deviations objected by the FDA. In the fiscal year 2007, production record review deviations were observed more than any other issue (together with Laboratory Controls - General Requirements). In the previous periods, observations regarding this subject were No.1 in 2005 and No. 2 in 2006 in the ranking of cited GMP deficiencies.
After a closer look at these citations, it becomes obvious that most observations are caused by failures in deviation management and CAPA. In most cases, deviations were noticed by the pharmaceutical company but no sound investigation was performed and no consequences were defined.
Examples are:

  • "failure to conduct adequate investigations, and notably, to properly extend failure investigations to all associated batches"
  • "no indication that the process deviations were promptly corrected"
  • "failure to follow written procedures pertaining to investigation follow-up and completion of corrective actions within specified timeframes"
  • "Specifically out-of-specification assay results for several of your drug products including [] and [] had no written investigations or documentation of corrective actions"

Current developments like FDA's published Quality System Guide, ICH Q10 and these Warning Letter citations clearly emphasise the increasing relevance of a proper deviation management and CAPA.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)



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