Pharmaceutical science association ISPE has released a new guidance document that defines best practices within pharmaceutical manufacturing applications in regards to gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams.
The document, titled “ISPE Good Practice Guide: Process Gases,” focuses on defining cost-effective engineering approaches and practices used to deliver a process gas system for a manufacturing facility in a timely manner that will meet its intended purpose. The guide provides information on how to avoid increasing facility installation and operation costs.
The primary focus of the guide is to address the process of designing, constructing, commissioning and qualifying a process gas system regulated by international regulatory authorities, including the Food and Drug Administration and the EMA. The guide promotes a science- and risk-based approach to provide an effective basis for this process and is intended to align with ICH Q9 and ASTM-E2500 principles.
For more information, visit http://www.ISPE.org.