Copyright 2004-08
Information Flow...during
Commissioning and Qualification
|
cGMP
Compliance...How information gets around...
|
Regulated Facilities
and
Processes
Engineering
Project
Management
Commissioning
Qualification
How
does information move from the Engineering Team to the Compliance
Team?...
During Validation information flow is critical...
All
Rights Reserved
Click on the image
at left for a diagram
describing information flow for
Commissioning efforts prior to the start of
Qualification
Phase...
|
Process
Validation follows the completion of the Qualification effort and bridges the
gap to
operational status of the system in question...
SOPs are
generated and Trial Batches are run prior to actual manufacturing
operations...
Ongoing manufacturing efforts will repeat and validate
these effort throughout the
manufacturing process...
Installation/
Operational/ Performance Qualification
|
IQ, OQ,
and PQ phases document installation, operational status, and performance
characteristics of the installed systems...
Information flows to the
field in the form of protocols to be executed and infromation flows back
to the Compliance Team in the form of execution records for the various
protocols...
and into the Compliance documents...
Click on the image
at left for a diagram
describing information flow from Compliance
Team to the field personnel executing the
protocols, and
back to the Compliance Team...
|
Commissioning will support the
Qualification efforts to follow for direct impact systems as part
of
the integrated approach as described in the C+Q Guidelines...
For
Indirect and no impact systems, standard commissioning practices are
sufficient...
