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Established engineering methods and standards that are applied throughout a project’s life cycle to deliver appropriate, cost-effective solutions.
Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition
Publication Date: 2007
A system whereby individual design decisions are performed by qualified personnel and documented so that they can be traced from user requirements through final design. GEP documentation considers purpose, responsible party, references, assumptions, calculation method, conclusions, and impact upon other facets of design. GEPs take industry practices, constructability, economics, regulatory requirements and safety into account.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
A combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities taking into account not only regulatory compliance but also safety, economics, environmental protection and operability. Standards and specifications are provided by recognized sources such as established engineering and architectural contractors as well as pharmaceutical companies. Codes are provided by local, state, or federal jurisdictions and/or insurance companies. Guidelines are issued by professional societies, industrial organizations, or regulatory agencies. Engineering design methods have been established throughout the engineering educational system.
Publication Source: ISPE Baseline® Guide, Vol. 4: Water and Steam Systems (Second Edition)
Publication Date: 2011
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