Post on 30-Dec-2015
description
©
Safeguarding public health
Workshop – Topic Areas
Name: Malcolm DashDate: 26 October 2009
Slide 226 October 2009
©
What are the characteristics of a good and poor assessment report?
Microsoft Word
Document
Slide 326 October 2009
©
What represents “poor use of resources” when it comes to writing assessment reports?
Microsoft Word
Document
Slide 426 October 2009
©
Discuss what you want/need to see in an RMS report
How much detail should be included?
Microsoft Word
Document
Slide 526 October 2009
©
Examples of good focused assessment reports
Microsoft Word Document
Microsoft Word Document
Slide 626 October 2009
©
Areas not well covered: GMP, sterilisation, BE, bioanalytical methods
Slide 726 October 2009
©
Topic areas
Analytical methods and reference standards
Pharmaceutical development
Stability
Impurities in API
Specifications
Dissolution testing
Slide 826 October 2009
©
Discuss the best ways to present information in the assessment report on the validation of an analytical method
Microsoft Word
DocumentMicrosoft Word
DocumentMicrosoft Word
Document
Slide 926 October 2009
©
Pharmaceutical Development & Manufacturing Process Development
Microsoft Word Document
Microsoft Word Document
Slide 1026 October 2009
©
Stability
Microsoft Word
DocumentMicrosoft Word
Document
Slide 1126 October 2009
©
What do we need to include in the AR to demonstrate that a company has addressed the issue of impurities in the finished product?
Microsoft Word Document
Microsoft Word Document
Microsoft Word Document
Microsoft Word Document
Microsoft Word Document
Slide 1226 October 2009
©
Specifications
Microsoft Word
DocumentMicrosoft Word
Document
Slide 1326 October 2009
©
When is it important to consider the discriminating nature / capability of a dissolution test?
Microsoft Word Document
Microsoft Word Document
Microsoft Word Document
Microsoft Word Document