Good Practice Guide: Quality Lab Facilities


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Published: September 2012
Pages: 176

ISPE produced the industry’s first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities that produce pharmaceutical products for human and animal applications. It provides a step-by-step process that guides the reader through all phases of producing a quality lab and all the factors that must be considered at each phase.

The Guide helps save time and money by facilitating effective communication between lab owners, engineers, and builders about the function, operation, and design parameters that must be met.