(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.”

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