Baseline® Pharmaceutical Engineering Guides for New and Renovated Facilities

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ISPE's Baseline GuidesCreated in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline® Guides offer practical answers to the complex, dynamic challenges facing facility designers today. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. Additionally, they address GMP and non-GMP regulations and detail facility commissioning and qualification.

Last Update: 09 November 2012

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VOLUNTEERS NEEDED

ISPE is seeking volunteers to serve on the Task Teams to develop upcoming Guidance Documents including Baseline® Guides. These highly sought-after positions help shape the Pharmaceutical Manufacturing Industry by bridging the gap between industry best practice and FDA expectations.

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