The learning outcomes for this module are as follows,
1. Explain the quality system requirements for daily operations within a pharmaceutical facility.
2. Explain how the pharmaceutical manufacturer’s quality system maintains a state of control.
3. Critically appraise the solid dose pharmaceutical and biotech manufacturing life cycles from product demand to product distribution.
4. Apply technical skills to identify and describe the components within a typical drug product formulation and their chemical function.
5. Describe pharmaceutical manufacturing processes for a solid dose pharmaceutical and biotech process.
6. Discuss the quality control testing requirements from raw materials to finished product for solid dose pharmaceutical products
7. Design a typical stability testing programme and drug product shelf life determination.
8. Define the principals of process, equipment and cleaning validation, and the requirements and importance of a robust change control system.