GMP
Good Manufacturing Practice (GMP) is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods. The priorities for GMP are to ensure safety and quality of the product.
Good Manufacturing Practices are enforced:
- In the United States by the Food and Drug Administration (FDA)
- In Europe by the European Medicines Agency (EMEA)
- In the United Kingdom by the Medicines and Healthcare Products Regulatory Agency (MHRA)
The International Conference on Harmonisation (ICH) is looking towards international standards for drug registration.[1]
Learning Objectives:
By the end of this module you should:
- Understand what is meant by the term ‘Quality’ in the context of the Pharmaceutical Industry;
- Be aware of the potential consequences of poor product quality to both the patient and to a pharmaceutical company;
- Be aware of what needs to considered to ensure the quality of a medicine.
- J. Molzon, The Common Technical Document: the changing face of the New Drug Application, Nat. Rev. Drug Discov., 2003, 2, 71-74.
- 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