96098: A Scientific Study to Support a Shelf Life - Report Writing Assignment Help

Assignment Task:

Task:  

Prepare a stability program to cover the required commitment studies as part of a new product application.  

For the purposes of this assessment, assume that the range of 9 products listed in the table below is a new range of products  for which pre-approval studies to support an application for approval in Australia have been done. As part of the submission  you need to describe your commitment to further studies, both the initial post-approval studies and your plan for ongoing  stability monitoring.  

You may assume that current studies have shown that each formulation (in its proposed marketing pack) shows good stability  trends for 6 months at accelerated conditions and 12 months at long term conditions (30deg/ 65% RH). All similar formulations  are showing similar trends. 2 pilot scale batches and 1 production scale batch were used to generate the pre-approval data.  

You may assume that products with the same name in ‘original’ and ‘colour free’ versions are different only in that there is no  colour in the ‘colour free’ version.  

You may assume that products with the same dosage form and the same active ingredients, contain the same excipients.  

While your marketing department is willing to accept a 2 year shelf life initially, they would like to later apply for a 3 year shelf  life if the data is suitable.  

Prepare a report describing the studies you would undertake to meet both post-approval and ongoing requirements. That is  there should be two stability plans. One for post-approval studies and one for ongoing studies. The report should address the  basic stability study design considerations listed below and reference the relevant regulations, standards and guidelines as  appropriate. 

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