This Technical Bulletin covers the definition and classification of gases used as active pharmaceutical ingredients (API) as specified in the European Guide to Good Manufacturing Practice (GMP).
It provides guidance regarding the definition and classification of the active substances used in the manufacturing of medicinal gases.
It aims at ensuring they meet requirements specified in the marketing authorisation. Most of the gases used as API starting materials are produced in manufacturing plants where the majority of the product is for industrial use compared to the smaller quantities required for use as API starting material.
Where the application of GMP II is not possible, it is replaced by the application of another suitable quality management system and supplemented by risk management and/or supplier audit.
The manufacturer of active substance is responsible for documenting the rationale for the definition of the point at which production of the active substance begins.
This Technical Bulletin is intended to be used by those seeking to define the point at which production of the active substance begins.