(TAMPA, FLORIDA, USA, 3 July 2012) – ISPE announced today 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.
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. ISPE will soon be recognized globally as the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical devices across the entire product lifecycle. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
For more information contact:
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277