New FDA Science Forum Documents on Dissolution Testing

GMP News No. 741

GMP News
30 May 2006

New FDA Science Forum Documents on Dissolution Testing

Of the FDA Science Forum 2006, which took place in Washington on 18-20 April 2006, two contributions concerning dissolution testing have been published:

Studies of Variability in Dissolution Testing with Apparatus 2

Repeatability and reproducibility in dissolution testing have been a critical point for many years. This study published by FDA representatives shows that in 70% of all cases, variability of results was due to the tablets themselves, in 25%, it depended on the dissolution equipment and in 5% of the cases, the fault lay with the lab staff.

Click here to read the abstract.

USP Apparatus 4 Dissolution Profile Prednisone Tablets Lot P

Here, USP employees checked if USP Prednisone Tablets Lot P can be used in flow-through cell apparatus. The summary points out that, at the very beginning of release testing, it can be critical to obtain reproducible test results. Click here to read the summary.

Besides, the FDA published a position paper of the US-American Generic Pharmaceutical Association (GPhA) titled <GPhA Proposed Pathway for Quality by Design Dissolution Testing and Setting Specifications for Generic Drugs>. This position paper deals with the difficulties faced by generics manufacturers in the context of dissolution testing.

A comprehensive training programme on this topic is offered by the ECA in the Summer Training Course Dissolution Testing in Copenhagen from 3-5 July 2006. Among the topics are the regulatory requirements and the development of release methods - up to the correct handling of OOS results in release tests.

In addition, the topics

  • Equipment qualification (including USP Calibrator Tablets)
  • Specifications
  • Validation of dissolution methods
  • Method transfer

are consolidated in Workshops.

Dr Günter Brendelberger
On behalf of ECA

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