GMP News No. 622
11 October 2005
Laboratory Activities 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:
Further references were made to personnel qualifications, laboratory records, reserve samples, special testing requirements and expiration dating.
|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".