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ISPE announces new guidance for PACLAW facilities

US-based International Society for Pharmaceutical Engineering (ISPE) said that it has released new guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities.

The guide has been designed to help firms meet CGMP requirements for these types of facilities along with helping them avoid product adulteration, product mix-up, label mix-up and misbranding.

The agency said that the guide features Food and Drug Administration (FDA) inputs and is the only guidance in the industry to offer this type for PACLAW facilities.

Guide Author Nick Davies said that the new ISPE Good Practice Guide will help ensure PACLAW processes are efficient with process comparisons to help establish best practices and demonstrate compliance to regulatory agencies.

The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities offers an approach to satisfying CGMPs along with providing realistic solutions to business and operational concerns.

The agency will address Quality by Design principles and establish consistent guidelines which could be incorporated into the design and/or reconfiguration of PACLAW facilities.

It includes facility design issues for primary packaging operations such as filling of the dosage form in the immediate container/closure system, and other packaging, labeling and warehousing processes.