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ISPE Releases New Guidance for Designing and Constructing Packaging, Labeling, and Warehousing Facilities

July 3, 2012

ISPE announced that it has released new guidance relating to the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The Guide helps companies meet CGMP requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up and misbranding. The Guide contains FDA input and is the industry’s only guidance of this type for PACLAW facilities.

“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. “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.”

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities presents an approach to satisfying CGMPs while providing realistic solutions to business and operational concerns. It addresses quality by design principles and establishes consistent guidelines that can be incorporated into the design and/or reconfiguration of PACLAW facilities. 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 the 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.