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?