ISPE Glossary of Pharmaceutical and Biotechnology Terminology
The operation techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
Publication Source: Committees on Human Research
The operational techniques and procedures used to achieve quality requirements.
Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
Publication Date: 2005
(ICH Q7)Checking or testing that specifications are met.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
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Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems
Publication Date: 2007
Checking or testing, that specifications are met, or the regulatory process through which the industry measures actual quality performance, compares it with standards, and acts on the difference.
Publication Source: ISPE Good Practice Guide: Technology Transfer
Publication Date: 2003
Group responsible for checking or testing that specifications are met.
Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
Publication Date: 2005
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