1. Name: Malcolm Dash Date: 26 October 2009
Workshop – Topic Areas
Name: Malcolm Dash
Date: 26 October 2009

2. What are the characteristics of a good and poor assessment report?

3. What represents “poor use of resources” when it comes to writing assessment reports?

4. Discuss what you want/need to see in an RMS report
How much detail should be included?

5. Examples of good focused assessment reports

6. Areas not well covered: GMP, sterilisation, BE, bioanalytical methods

7. Topic areas
Analytical methods and reference standards Pharmaceutical development Stability Impurities in API Specifications Dissolution testing

8. Discuss the best ways to present information in the assessment report on the validation of an analytical method

9. Pharmaceutical Development & Manufacturing Process Development

10. Stability

11. What do we need to include in the AR to demonstrate that a company has addressed the issue of impurities in the finished product?

12. Specifications

13. When is it important to consider the discriminating nature / capability of a dissolution test?