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Jennifer Markarian is manufacturing editor of BioPharm International.
Guide helps companies meet CGMP requirements.
The International Society of Pharmaceutical Engineering (ISPE) released guidance for the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities. The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities helps companies meet CGMP requirements for PACLAW facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
“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 in a July 3, 2012 press release. “With this ISPE 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 guide gives direction on designing or reconfiguring PACLAW facilities using quality by design principles. It also explains how PACLAW facilities can comply with FDA’s systems-based approach, which uses a risk-based inspection model.