The USA are the most important pharmaceutical market in the world.
Therefore, it is always interesting to read inspection results of the
American registration and supervisory authority.
Within the framework of a PowerPoint® presentation, the FDA
published - quite recently - inspection results of the year 2004/2005. The
presentation is highly interesting because it focuses among others on new
statistics on FDA's foreign inspections conducted in fiscal year
The presentation deals in detail with FDA's "System-Based
Approach" introduced by the Agency in 2002 as a new inspection
procedure. The systems checked include the quality system, facilities and
equipment system, materials system, production system, packaging and
labelling system, and the quality control system.
By means of this approach, the FDA expects to reduce the inspection
time on site and to be able to transfer the results of individual systems
to the GMP compliance of the firm as a whole. Proceeding in this way, the
FDA sees parallels between its inspections and in-house QA activities. It
distinguishes between "full inspections" including four systems
and "abbreviated inspections" comprising only two systems. What
is always checked is the quality system.
The presentation then points out the distribution of the foreign
inspections (illustration 1). A conspicuous feature is the high
percentage of inspections in Germany, which is as high as the percentage
of inspections conducted in India.
Illustration 1 Foreign Inspections by Country in Fiscal Year 2004
Illustration 2 shows a list of foreign inspections by firm type. Here,
a trend of the past years is continued: By far most of the inspections
(more than 50%) are conducted at the sites of API manufacturers, followed
by dosage manufacturers.
Illustration 2 Foreign Inspections in Fiscal Year 2004 by Firm Type
Illustration 3 lists the GMP deficiencies for foreign dosage
manufacturers. At the top of the list of directly assignable deviations,
there are failures and OOS investigations, lab controls come second,
equipment/cleaning validation ranks 3rd followed by a number of other
Illustration 3 GMP Deficiencies for Foreign Dosage Manufacturers in
Fiscal Year 2004
If GMP deviations of API manufacturers are included, the distribution
of the (assignable) top three looks quite different (see illustration 4):
deficiencies in environmental controls and in production/process controls
share the first place, followed by lack of/inadequate SOPs.
Illustration 4 GMP Deficiencies in API/Dosage Manufacturers in Fiscal
Another pie chart (see illustration 5) shows the distribution of GMP
deviations in relation to the six systems. Unfortunately, these data only
refer to inspections within the US. Nevertheless, the distribution is very
revealing. With nearly 50% of deviations, the quality system is clearly in
the lead. The laboratory system is in second place followed by the
production system. The facilities/equipment system and the materials
system come 4th and 5th, having similar percentages.
There were no findings for the packaging and labelling systems.
Illustration 5 Most Common GMP Deficiencies by System - Domestic
Inspections for 2004/5
The presentation ends by giving examples for FDA-483 citations.
If you would like to download the original version of the PowerPoint®
presentation, please click here.