Engineering For Sterile Product Manufacturing Facilities

By Elomatic India and Heikki Niskanen

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.

It is noteworthy that most GMP regulations describe what needs to be accomplished, rather than how it should be accomplished. A disciplined approach is, therefore, required to meet the requirements.

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. An overview of the relevant regulatory authorities and their publications is provided in the info box (see overleaf ).