TRAINING

Dedicated on-site Tablet Dissoution Training Course

In the pharmaceutical industry, dissolution testing is a critical step in quality control and a standard method for assessing batch-to-batch consistency of solid oral drug delivery systems, such as tablets.

This course concentrates on USP I and II methods as described in USP General Chapter <711>

The course has been specifically designed for users of dissolution equipment who are involved in the day to day preparation, running, and analysis of samples by dissolution, and offer comprehensive information about the theory and practice of running dissolution, calibration, and validation issues and what to do if things go wrong.

This is a 1 day course for a max of 6 analysts.



Topics Covered

1) Historical highlights of dissolution
» Theory
» Definitions
» Factos influencing the dissolution rates
» Significance of dissolution training

2) Performance Verification Testing
» PVT: Current approach, ISO framework, and proposal
» Elements of Routine Maintenance
» The Performance Verification Test. When to perform?
» Sources of Error

3) Practical: Putting it all together
» Prednisone testing
» Medium Preparation and Equipment Set-up
» Analyst training
» Variables
» Acceptance criteria
» Review results