About this document
GMP Guidelines for Non-Traditional APIs by lanikhil is a document available to read on EtoBox.
The document provides guidance for dosage form manufacturers using non-traditional active pharmaceutical ingredients (APIs) from starting material manufacturers that cannot fully comply with Good Manufacturing Practice regulations due to scale. There should be a specification and agreement between suppliers and purchasers detailing key processing parameters. Starting material manufacturers should control these parameters and notify purchasers of any changes. Dosage form manufacturers should audit suppliers,
- Author
- lanikhil
- Language
- EN