GMP in the Pharmaceutical Industry
In this video, Andy Wells provides some background information as to why GMP was initiated, before going on to describe GMP categories, organisational controls and what constitutes a validated process to produce a drug substance. Finally, consequences of failure to observe GMP are summarised.
- Route Selection
- GMP
- Introduction to Process Engineering
- Route Selection and Scale Up: Case Study and Exercise
- Process Safety
- Reactive Hazards in Scaling Up: Case Study and Exercise
- Design of Experiments
- Some Definitions
- The Experimental Design Process
- Comparing Traditional Approaches to Experimental Design
- Examples of Variables and Responses for a Chemical Process
- Main Effects and Interactions
- Experimental Designs: Factorial Designs
- Experimental Designs: Response Surface Design
- Design of Experiments: Summary and Further Reading
- Reaction Work-up and Product Isolation
- Environmental Legislation
- Abatement and Waste Treatment