ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English


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

Publication Date: 2004

See also: Parameter 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


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

Do you have a term that should be included in the glossary?
Submit a term for review


  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift