Process design

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: ).

ICH guideline Q11 on development and manufacture of drug substances (Last accessed: ).

EMEA Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances (Last accessed: ).

GMPs for APIs: "How to do" document (Last accessed: ).

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.