Abstract

The U.S. Food and Drug Administration regulates outsourcing facilities with the same stringency they apply towards drug manufacturers. This means that outsourcing facilities, who must navigate the changing regulatory landscape to achieve and maintain 503B status, need to focus on qualifying container closure systems for their intended use. Container closure systems must be fit-for-purpose (i.e., suitable for in-use conditions relative to drug product stability over intended shelf-life and storage conditions). This article, the first of a two-part series, addresses the critical aspect of how to qualify systems for intended use regarding container closure integrity. The second part will address component selection.

Related Keywords

• drug container closures
• drug contamination
• drug safety regulations
• Current Good Manufacturing Practice
• CGMP
• Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
• 503B status
• container closure integrity
• fit for purpose
• intended use
• maximum allowable leak limit
• sterile compounding
• United States Pharmacopeia <1207> Packaging Integrity Evaluation--Sterile Products
• USP
• vial systems
• stopper systems
• seal systems
• helium leak method
• oxygen headspace method
• residual seal force method
• compression
• microbial contaminants
• drug contamination

Related Categories

• LEGAL
• PACKAGING
• STERILE PREPARATIONS
• QUALITY CONTROL
• STORAGE