FDA Has Published Additional HUMAN DRUG CGMP NOTES

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.