ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Installation Qualification (IQ)

The documented verification that the facilities, systems and equipment, as installed or modified,comply with the approved design and the manufacturer’s recommendations.

Publication Source: ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

Publication Date: 2011

Installation Qualification (IQ)

(FDA) Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer's recommendations are suitably considered.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

Installation Qualification (IQ)

Establishing documented evidence that the key aspects of the purchased item or installation conform to approved written specifications and/or drawings.

Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)

Publication Date: 2010

Installation Qualification (IQ)

Documented verification that all aspects of a facility or system, that can affect product quality, adhere to approved specifications and are correctly installed.

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Manufacturing Facilities (First Edition)

Publication Date: 2011

Installation Qualification (IQ)

Documented verification that a system is installed according to written and pre-approved specifications.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Installation Qualification (IQ)

Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions, and that the recommendations of the manufacturer have been suitably considered.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Installation Qualification (IQ)

For “Direct Impact” systems, the documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (e.g., construction, materials) and is correctly installed.

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

Publication Date: 2007

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