Dissolution Testing in Human Drug CGMP Notes

GMP News No. 455

GMP News
23 August 2004
 

Dissolution Testing in Human Drug CGMP Notes

 
The FDA received inquiries regarding dissolution testing from some FDA Investigators as well as from members of the pharmaceutical industry. What kinds of USP dissolution test failures are significant enough to be noted on Forms 483? Is a failure in dissolution testing at stage 1 level, for instance, significant enough to be cited on an FD-483?

In the Human Drug CGMP Notes of March 1995 and March 1996, the FDA clarified this question to the satisfaction of the pharmaceutical industry:

"Routine failure of manufactured batches of a product to pass USP Dissolution tests at Stage 1 is not significant enough to be noted on Forms FD-483; neither is occasional failure of individual dosage units at Stage 2. A batch does not fail the USP Dissolution Test until it fails at Stage 3. However, frequent failures at Stage 2 are significant when other batches of the same product have Stage 3 failures, and therefore should be noted on Forms FD-483."

The above paragraph is meant to summarise the most important statements on dissolution testing in the Human Drug CGMP Notes.

A very topical publication on dissolution testing dating from 2003, which has been created with FDA's co-operation, are the "FIP/AAPS Guidelines to Dissolution/in Vitro Release Testing of Novel /Special Dosage Forms." You can download them by clicking here.
  

Dissolution testing of special dosage forms, like suspensions, suppositories, creams, ointments, is one of the topics covered by the ECA conference "Quality Aspects of Dissolution Testing" to be held on 29 and 30 September 2004 in Zurich, Switzerland. Ten speakers from the pharmaceutical industry and from authorities inform you about current topics, e.g.:

  • UV-Fibre Optical Measurement
  • Automated Dissolution by at-line IPC
  • Harmonisation of Pharmacopoeial Requirements
  • Registration Requirements for Dissolution Testing
  • Development and Validation of Dissolution Methods

This link will lead you to the complete invitation programme for this conference.

 
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
  

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