Good Practice Guide: Quality Laboratory Facilities

Good Practice Guide: Quality Laboratory Facilities cover image

Title:

Good Practice Guide: Quality Laboratory Facilities

Author(s):

Butler, Mark A.; Craft, Mary Ellen; Creaven, Thomas J.; Daou, Cesar B., PE; DeFreitas, Donna A.; Dolceamore, James J.; Ferguson, William E., PhD; Fricke, Frederick L.; Gardner, Peter B.; Gonzalez, Michelle M., PE; Guillorn, Gerard J.; Jacobs, Terry A., AIA; Master, Kaushik S.; Middelber, Catherine E.; O'Brien, James M.; Smith, Euan D.; Snyder, Kimberly D.; Tewalt, Gregory L., PhD

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Author(s): Butler, Mark A.; Craft, Mary Ellen; Creaven, Thomas J.; Daou, Cesar B., PE; DeFreitas, Donna A.; Dolceamore, James J.; Ferguson, William E., PhD; Fricke, Frederick L.; Gardner, Peter B.; Gonzalez, Michelle M., PE; Guillorn, Gerard J.; Jacobs, Terry A., AIA; Master, Kaushik S.; Middelber, Catherine E.; O'Brien, James M.; Smith, Euan D.; Snyder, Kimberly D.; Tewalt, Gregory L., PhD

ISPE has 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 producing 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.

Table of Contents

Good Practice Guide: Quality Laboratory Facilities

Pages: 176
Published: September 2012