Since the publication of 21 CFR Part 11 in 1997, FDA has issued or
announced a great number of Draft Guidances for Industry as interpretation
aid. However, rather than facilitating the implementation of 21 CFR Part
11, these documents have shown the tendency to make it even more
During the last few weeks, there have been several announcements by FDA
to rethink the Part-11 regulations, above all in order to find a risk-based
approach to Part-11 implementation within the framework of the "CGMP Initiative"
announced on 21 August 2002.
In this context, ISPE has published a White Paper for commenting by the
industry - maybe in part at the request of PDA - that is meant to answer
the most important questions.
The following key topics are discussed:
- Definition of "electronic records"
- Audit trails
- Retention and maintenance of records
- Electronic copies for inspection
- Hybrid and procedural solutions
- Application of electronic signatures
The essence of the document is that the GxP risk (risk to the patient
or to product quality) should be analysed in each case individually and
that further measures should be taken on the basis of the risk analysis. For the example of electronic records, this means that batch
records and laboratory test results are considered to be highly GxP
critical, while e.g. records of personnel training measures are classified
as comparatively uncritical.
Records that relate directly to the product are thus considered to be
highly critical and, therefore, their integrity has to be assured in any
case, whereas less effort is required with regard to data that are not
directly product-related - and therefore less critical.
On the whole, this Initiative is a good thing and might have been
applied similarly in the world of GMP up to now. It is to be hoped,
however, that the problems will not shift towards the question of
"what is GMP critical."
leads you to the White Paper.
Dr Andreas Mangel