GMP News No. 299
2 April 2003
With 30 Warning Letters, "Written procedures; deviations" ranks first, followed by "Testing and release for distribution" and "Responsibilities of the quality control unit" with 28 and 27 WLs respectively. Then come "Laboratory controls - General requirements," "Production record review," and "Batch production control records" with 24, 22, and 20 WLs.
From this list, one can deduce that FDA carries on inspecting especially the quality control departments according to its system-based approach. In doing so, the Authority's main questions are:
These are still the points where most deviations are found.
Other topics that have become the focus of FDA's attention refer to:
The following graph shows the ranking of the individual references to 21 CFR § 211 from 2002 (percentage of WLs in relation to the sum of the 10 most frequent citations; absolute figures in parentheses).
The following events focus especially on FDA requirements: