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ISPE

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ISPE Releases New Guidance for Designing and Constructing PACLAW Facilities

The industry’s only guidance of this type for PACLAW facilities

Published: Thursday, July 5, 2012 - 11:46

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released its new guidance relating to the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The guide helps companies meet current good manufacturing practices (CGMP) requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up, and misbranding. The guide contains input from the U.S. Food and Drug Administration (FDA) 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,” says 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 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.

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ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a global nonprofit association of 22,000 pharmaceutical professionals in 90 countries who use knowledge to create high-quality, cost-effective good manufacturing practices (GMP) solutions. ISPE provides its members opportunities to develop technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning for a global audience. Its world headquarters are in Tampa, Florida, with offices in Brussels, Belgium, Shanghai, China, and Singapore.