[miah]

You are the Lead Analytical Chemist at Front Line Pharma.  One of the Front Line Pharma manufacturing sites produces a Chemical entity called Biotin. 
 
The process was developed in pilot plant (R&D)

Average yield       80% theory,          

Average assay       98.5% w/w.

The process was transferred into manufacturing (Primary Supply) and commissioned successfully.
The product was launched in all world markets and the process registered with regulatory authorities including the following information

Yield range          75% - 85% theory      
Assay specification limit    Not Less Than 97% w/w

Since commissioning 50 batches have been produced to date with each batch worth £100,000.= 5,000,000
For these 50 batches manufactured in Primary Supply the following information

Average yield       65% theory (2 less than 55% theory)
Average assay      97.2% w/w (range 96.7 to 97.7%

Your presentation will be put forward to the Board of Directors as the direction to move forward.

1.   What are the key issues?
2.   Given the appropriate resources what would your course of action be?
3.  How would you demonstrate that your answers/findings are valid?