GMP News No. 262
14 November 2002
Systems Inspections 2002 FDA's New Approach to Inspections
Fred Blumenschein from CDER says that, by means of the new method, FDA intends to systematise their inspections and improve their focus and efficiency. The improved organisation of FDA 483 documents and Establishment Inspection Reports (EIRs) will represent an added benefit.
Within the framework of Systems Inspections, either a "Full Inspection" (4-system) or an "Abbreviated Inspection" (2-system) will be conducted. What is always inspected is the Quality System and at least one of the remaining systems.
Full Inspections are carried out in case
of initial inspections, significant changes regarding personnel or
operations, and compliance inspections, i.e. if deficiencies in the GMP
implementation were found in the past. In other cases, an Abbreviated
approach will be taken. The crucial point are no longer the individual
profile classes, but different product classes. Of course, if significant
deficiencies are found, the individual products or batches are examined.
However, also in this case across the system limits.
If a Warning Letter has been issued after
the last inspection, a Full Inspection will be conducted.
This line of argumentation of FDA is the exact point of reference for an industry comment (Dr S. Nair, QM, Hoffmann-La Roche). It recommends that one should align one's quality system to the 'new' FDA requirements. However, it emphasises that the most important factor for success is advance preparation.
Apart from profound system knowledge, it is essential to have a well-trained inspection team to accompany the FDA inspector.
Source: PDA Letter, August 2002
In the meantime, the first experiences have been made with FDA's System Inspections. Dr Reiner Kirrstetter, Aventis Pharma AG, D-Frankfurt, and Richard M. Bonner, Eli Lilly, UK-Liverpool, reported about them on the occasion of the ECA Education Course "GMP Compliance Auditor" in Hamburg on 16-17 October 2002.
Here some examples:
Different requirements stipulated during FDA System Inspections:
Both speakers also stressed that a thorough preparation is a key element to an FDA System Inspection. This is, of course, true of all other GMP inspections as well.