ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Monitoring

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

See also: Parameter Monitoring

Monitoring

Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, Good Clinical Practice and by regulatory requirements.

Publication Source: Committees on Human Research

See also: Site Visit

Monitoring

Observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation.

NOTE: This information may be used to detect trends in operational state and to provide process support.

Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions

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