ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Functional Design Specification (FDS)

Description of acceptance criteria, in terms of ranges and logic of operation etc.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001

Functional Design Specification (FDS)

Provides the functional design requirements. The FDS says how the direct impact water or steam system will perform its function. Typically, the FDS is tested or verified during commissioning or qualification.

Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Publication Date: 2007

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