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Safeguarding public health

Workshop – Topic Areas

Name: Malcolm DashDate: 26 October 2009

Slide 226 October 2009

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

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Slide 326 October 2009

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

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Slide 426 October 2009

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Discuss what you want/need to see in an RMS report

How much detail should be included?

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Slide 526 October 2009

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Examples of good focused assessment reports

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Slide 626 October 2009

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

Slide 726 October 2009

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Topic areas

Analytical methods and reference standards

Pharmaceutical development

Stability

Impurities in API

Specifications

Dissolution testing

Slide 826 October 2009

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

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Slide 926 October 2009

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Pharmaceutical Development & Manufacturing Process Development

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Slide 1026 October 2009

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Stability

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Slide 1126 October 2009

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

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Slide 1226 October 2009

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Specifications

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Slide 1326 October 2009

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

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