Discuss the importance of risk assessment in the pharmaceutical/biopharmaceutical sector. Discuss the significance of the ICHQ9 guideline, and how it might be applied. Use examples to support your writing where possible.
Explain the modern-day Quality system, differentiate between the older approach, and explain why and how there are benefits to using a modern Q10 Pharmaceutical Quality System. Include the component parts of a QS that you believe are essential and the reasons why. Use examples to support your writing where possible.
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