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.
- "failure to conduct adequate investigations, and notably,
to properly extend failure investigations to all associated batches"
- "no indication that the process deviations were promptly
- "failure to follow written procedures pertaining to
investigation follow-up and completion of corrective actions within
- "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.
On behalf of the European Compliance Academy (ECA)