Following Best Practices In The Design Of A Pharmaceutical Manufacturing Facility

By Tam Huynh, QMC director at PharmaLex

The concept design review is a crucial step in pharmaceutical facility design, providing a platform to visualize the building layout, spatial arrangements, and the flow of personnel and materials. This review allows subject matter experts to evaluate and communicate the finer details of process and quality requirements to designers.

To ensure compliance with regulatory standards such as 21 CFR 211 and Eudralex Volume 4, Annex 1, a thorough review of the conceptual design is essential. This includes assessing department areas, labs, common spaces, and cleanrooms, focusing on the efficient flow of personnel and materials. By adhering to best practices and considering factors like cleanroom classification, airlocks, and pressure differentials, pharmaceutical companies can design facilities that prioritize safety, quality, and regulatory compliance.

To learn more about the key considerations in pharmaceutical facility design, read the full article.