Glossary

Country-of-Origin Labeling

Continuity of Operations Plan

Community of Practice (ISPE term)

Critical Operating Parameter

Coastal Ocean Program (NOAA)

Clean Out of Place

An automated or semi automated procedure in which the process equipment is disassembled and its components are placed into an agitated fluid bath of cleaning solutions. Baskets may be utilized to hold and wash smaller parts such as gaskets, clamps, valve bodies, PD pump rotors, etc. The cleaning is normally done with a proprietary acid or caustic-based detergent, or a combination of both, with a Compendial Water rinse.

Community of Practice Council (ISPE term)

Chronic Obstructive Pulmonary Disease

A polymer formed from two or more different monomers.

Council of Public Representatives (NIH OD)

Community Oncology and Prevention Trials Research Group (NCI)

When used in the context of global information systems, the processes, functionality, tasks or other elements that are identical across all implementations. These are generally managed centrally.

EASE Central Repository Module

Functionality of the computer system that is identical across local implementations.

Processes that should be carried out the same way across all implementations of the global system.

Validation activities that can be performed once and shared with teams working on local implementations. These activities need not be repeated locally.

Team with responsibility for core validation activities. This team may have other global responsibilities, such as coordination local efforts.

An ingredient in the culture medium for producing penicillin. A natural nitrogenous material that is a by-product of the corn milling industry.

(IEEE) A routine that begins execution at the point at which operation was last suspended, and that is not required to return control to the program or subprogram that called it.

(ISO 8402) Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence.

(ICH Q10) Action to eliminate the cause of a detected non-conformity or other undesirable situation. NOTE: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. (ISO 9000:2005)

Action to be taken when the results of monitoring indicate that alert or action levels are exceeded.

A concept within GMP, which focuses on the systematic investigation of non-conformity, defects, or undesirable situations in an attempt to prevent their reoccurrence and/or occurrence.

A system for implementing correction actions and preventive actions resulting from an investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.