Differences between the manufacture of APIs and medicinal products

Gnibl R (2022)


Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 21

Pages Range: 12-17

Journal Issue: 2

Abstract

There are many parallels between the good manufacturing practice (GMP)-compliant manufacture of active pharmaceutical ingredients (APIs) and the production of medicinal products, as the comparison of EU Guidelines to GMP Part I for medicinal products and EU Guidelines to GMP Part II for APIs show. There are however also a number of important differences to be considered if manufacturers of APIs are to stay within the official requirements, thus ensuring GMP compliance.

How to cite

APA:

Gnibl, R. (2022). Differences between the manufacture of APIs and medicinal products. GMP Review, 21(2), 12-17.

MLA:

Gnibl, Rainer. "Differences between the manufacture of APIs and medicinal products." GMP Review 21.2 (2022): 12-17.

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