Statistics on FDA Inspections

GMP News No. 631

GMP News
25 October 2005

Statistics on FDA Inspections

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 2004.

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 deviations.

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 Year 2004

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.

The European Compliance Academy organises tailored FDA Compliance Seminars on the topics mentioned above, e.g.:

Topic Seminar
Inspection How to Pass EU and FDA Inspections
Quality System FDA's New Quality Systems and Risk Approach
Quality Unit FDA and GMP Compliance in Quality Assurance Units
Water System Pharmaceutical Water Systems
Quality Control FDA Compliance in Analytical Laboratories
There are also seminars on hot FDA topics for 2006 already available. You will receive a 5% discount (ECA Members 10% + 5%) if you book one of the 2006 ECA events until 30 November 2005, e.g.
Topic Seminar
OOS Handling Out-of-Specification Results
Please note: Events that are co-sponsored by other organisations may not have an early-bird price.
Sven Pommeranz

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