ISPE, the International Society for Pharmaceutical Engineering, offers new guidance on the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The "ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities" is intended to help companies meet CGMP requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up and misbranding, ISPE reports.
“PACLAW facilities are very different from other types of pharmaceutical facilities, and up until this point, there has been no consistent guidance available to help companies ensure compliance,” said Guide Author Nick Davies, in a press release. “With this ISPE Good Practice Guide, the industry finally has tools to ensure their PACLAW processes are efficient, compare their processes to established best practices, and demonstrate compliance to regulatory agencies.”
Featuring FDA input, the guide addresses Quality by Design principles and establishes consistent guidelines that can be incorporated into the design and/or reconfiguration of PACLAW facilities, ISPE reports. It covers facility design issues for most primary packaging operations, such as filling of the dosage form in the immediate container/closure system, and other packaging, labeling and warehousing processes. The Guide also provides direction on how to comply with FDA’s systems-based approach with a risk-based inspectional model as it relates to PACLAW facilities.
The "ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities" is available for purchase from ISPE at www.ISPE.org/PACLAWFacilitiesGuide.