GMP: Summary and Further Reading
Following Good Manufacturing Practice (GMP) is essential to ensure drug products are pure, safe and effective. Failure to observe GMP can have serious consequences.
Recommended reading:
ICH Quality Guidelines pharmaceutical quality based on Good Manufacturing Practice (GMP) (Last accessed: August 2022 ).
ICH guideline Q11 on development and manufacture of drug substances (Last accessed: August 2022).
EMEA Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances (Last accessed: August 2022).
GMPs for APIs: “How to do” document (Last accessed: August 2022).
For further information specifically on the ideal characteristics of a manufacturing route to an API; the quality requirements for the manufacture of an API and the potential sustainability impact of these requirements please read:
J. Hayler, From Discovery to Manufacturing: Some Sustainability Challenges Presented by the Requirements of Medicine Development, in Green and Sustainable Medicinal Chemistry: Methods, Tools and Strategies for the 21st Century Pharmaceutical Industry, L. Summerton, H. F. Sneddon, L. C. Jones and J. H. Clark, Royal Society of Chemistry, Cambridge, UK, 2016, ch. 8, pp. 82-100.
- 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