Laboratory Activities in the Focus of FDA Inspectors

GMP News No. 622

GMP News
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:

  • 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 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".


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