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GMP News No. 741
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
are consolidated in Workshops.