1 / 13

Best Practices in Writing Assessment Reports for Pharmaceutical Development and Manufacturing

Explore characteristics of good vs. poor assessment reports, resource utilization, focusing on RMS reports, and presenting analytical method validation. Address areas like API impurities, dissolution testing, and GMP considerations in assessment reports.

morrill
Download Presentation

Best Practices in Writing Assessment Reports for Pharmaceutical Development and Manufacturing

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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?

More Related