11 October 2005
in the Focus of FDA Inspectors
The March 2005 issue of the Gold Sheet states that the number of warning
letters issued by FDA in Fiscal Year (FY) 2004 is nearly the same as in
the previous FY (29 in 2003; 30 in 2004). It is a very positive
development for the pharmaceutical industry that the FDA is still issuing
warning letters on a quite restrictive basis.
At the same time, the warning letters are a good indicator for those
GMP areas at which the FDA has an especially close look in the
pharmaceutical companies. Laboratory activities are clearly one of the
targets. Among the top ten deviations in warning letters are:
- Stability testing
- Written procedures and deviations
- QC unit responsibilities
- Laboratory controls
- Release testing
Further references were made to personnel qualifications, laboratory
records, reserve samples, special testing requirements and expiration
|The GMP Education Course FDA-Compliance
in Analytical Laboratories, to be held in Dublin on
9-11 November 2005, helps you to prepare yourself and your lab
thoroughly for the current GMP and FDA requirements and their
interpretation in the quality control of the pharmaceutical industry.
Within 3 days, you will learn from industry speakers (among others Altana, Lilly, Sanofi-Aventis)
how the implementation into practice can be done today.
In the same week, the GMP
Education Course Analytical Data – Interpretation and Treatment,
to be held in Dublin on 7-8 November, deals with the statistical aspects
of the evaluation of analytical data. This course is based on the
requirements of the new USP General Chapter <1010>. In small groups
and workshops, you will learn to calculate the most important statistical
characteristics in practice.
Dr Günter Brendelberger
PS: The participants in these two events will be granted
a 15% discount on the price of the new book by Dr Joachim Ermer
"Validation in Pharmaceutical Analysis".
The information in this article may be outdated. In order to find updated information on this subject (e.g. new developments, training courses) please enter a keyword into the search engine at the top of this page.
You may also use our GMP Guideline Database to search for the current Guidelines.
If you want to receive the latest information about major GMP developments on a regular basis you may want to register for our
free GMP Newsletter.