As indicated in the GMP News on the ECA's Warning Letter Report, Production Record Review deviations are (again) the most frequent GMP observation made by the FDA. In the previous periods, observations regarding this subject were always No.1 or No.2 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.
Current developments like FDA's published Quality System Guide, ICH Q10 and those Warning Letter citations clearly emphasise the increasing relevance of a proper deviation management and CAPA.
CONCEPT HEDEILBERG (a service provider entrusted by the ECA Foundation)