Need to Avoid Product and Label Mix-Ups? Try New ISPE Guide
ISPE released new guidance relating to the design, construction, 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 U.S. Food and Drug Administration input.
"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 the guide's 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 (www.ISPE.org/PACLAWFacilitiesGuide).
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions.
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is available for purchase
First published on Healthcare Packaging.
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