Name: Malcolm Dash Date: 26 October 2009

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Presentation transcript:

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

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

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

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

Examples of good focused assessment reports

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

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

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

Pharmaceutical Development & Manufacturing Process Development

Stability

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

Specifications

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

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