ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities PDF

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry’s only 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. Companies can use this Guide to learn how to ensure that their PACLAW processes are efficient, compare their processes to established best practices and demonstrate compliance to regulatory agencies. This Guide 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.