FDA Has Published Additional HUMAN DRUG CGMP NOTES

GMP News No. 409

16 April 2004

FDAHas Published Additional HUMAN DRUG CGMP NOTES

The FDA has recently published very early editions of the Human Drug CGMPNotes (at http://www.fda.gov/cder/dmpq/index.htm).In total there are eight additional "CNOTES" from Paul Motisedated from 1993 and 1994.

On the whole, this is a good thing. However, many of the guidelinesmentioned there that are referenced in the answers to the enquiries arenot in force any more. For this reason, many of the statements are veryinteresting in principle, but due tonewer guidances that have come into effect during the past 10 years (e.g.the ICH Guidelines for Active Pharmaceutical Ingredients or on StabilityTesting), they are not valid any more.

Some items, nevertheless, are still valid, for instance the questionrelating to the raw laboratory data (Human Drug CGMP Notes, December1993), where the following alternatives are given for a FDA-compliant rawdata 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 CGMPNotes December 1993): the time period of 20 business days mentioned in the"Guide to Inspections of Pharmaceutical Quality ControlLaboratories" (July 1993) should not be viewed as a requirement. TheCGMP regulations do not specify a time frame for investigations becausewhat is appropriate depends on the circumstances. Any investigation,however, must be timely, based on the nature, scope, and costumer impactof the problem.

Dr Günter Brendelberger


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