The FDA has recently published very early editions of the Human Drug CGMP
Notes (at http://www.fda.gov/cder/dmpq/index.htm).
In total there are eight additional "CNOTES" from Paul Motise
dated from 1993 and 1994.
On the whole, this is a good thing. However, many of the guidelines
mentioned there that are referenced in the answers to the enquiries are
not in force any more. For this reason, many of the statements are very
interesting in principle, but due to
newer guidances that have come into effect during the past 10 years (e.g.
the ICH Guidelines for Active Pharmaceutical Ingredients or on Stability
Testing), they are not valid any more.
Some items, nevertheless, are still valid, for instance the question
relating to the raw laboratory data (Human Drug CGMP Notes, December
1993), where the following alternatives are given for a FDA-compliant raw
data documentation:
- Bound notebooks
- Prenumbered analytical sheets for which there is accountability
- Electronic systems (the system has to be validated)
Or another question refers to Failure Investigation (Human Drug CGMP
Notes December 1993): the time period of 20 business days mentioned in the
"Guide to Inspections of Pharmaceutical Quality Control
Laboratories" (July 1993) should not be viewed as a requirement. The
CGMP regulations do not specify a time frame for investigations because
what is appropriate depends on the circumstances. Any investigation,
however, must be timely, based on the nature, scope, and costumer impact
of the problem.
Documentation in QC Laboratories is also covered at the ECA Education
Course "FDA
Compliance in Analytical Laboratories", which takes place on 28
– 30 April 2004 in Heidelberg. This course deals with the key compliance
issues for analytical laboratories in a FDA regulated environment. Some of
the topics will be further deepened in workshops:
- Out of Specification Results
- Analytical Method Transfer
- Method Validation
- Validation of Excel Spreadsheets
The seminar is recognised within the framework of the "GMP Certification Programme"
of the European Compliance Academy. If you would like to know more about
this additional qualification, please click here.
In addition to the Education Course, the European Compliance
Academy offers a two-day statistics workshop titled "Analysis
of Analytical Data," to be held on 26 and 27 April 2004 in Heidelberg,
Germany.
