Article | September 21, 2017

Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities

Source: Daiichi Jitsugyo (America), Inc.

By Heikki Niskanen and Elomatic India

Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities

Processing of sterile medicinal products is one of the most critical operations in pharmaceutical manufacturing due to the highly technique-driven processes and the potential detrimental impact on patients. Since sterile manufacturing is subject to inspections by different regulatory authorities, such as the US FDA, WHO and EMA, it is imperative to be thoroughly familiar with Good Manufacturing Practice (GMP) regulations and their application.

This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects. It should be remembered, however, that engineering is only the basis and that quality assurance is vitally important. Manufacturing must strictly follow the carefully established and validated methods of preparation and prescribed procedures. 

Daiichi Jitsugyo (America), Inc.