The GMP CB
Operating Sytem...Explained
|
The
System- The GMP Operating System is a
systematic approach which provides a
comprehensive approach and
explanation of GMP Compliant engineering, construction,
commissioning,
and qualification for capital project execution that are subject to regulation
by
the FDA.
This detailed explanation provides specific
processes and procedures in an overall
framework of a complete project
life-cycle.
Copyright 2004-08
All
Rights Reserved
OS
Diagram (OSD)- a graphic explanation of the
system- a project road map. This document
is organized by phase
beginning with project initiation through Validation to ongoing GMP
operation. The diagram outlines different procedures and requirements
for facilities,
equipment, and utilities.
The design,
construction, and qualification of a GMP compliant facility requires a diligent
effort
to coordinate and control an immense array of issues in order to
result in an effective delivery
of the required facility.
Ineffective management and control of these issues can add
significant costs and delays to a project lifecycle.
A systemic
approach is proposed in order to ensure that efforts associated with a capital
project result in delivering a facility that meets user requirements in
a compliant manner.
An operating framework which provides an systemic
approach to compliance over the total life
cycle of a project from
project initiation through engineering, construction, commissioning,
qualification, process validation and on-going operation. The
approach documents the
relationship and flow of information between
user requirements, engineering efforts,
commissioning and validation
master plans, and process validation efforts. The system is
organized and executed around compliance as the fundamental priority and
results in all
aspects of the all efforts associated with designing and
constructing a new facility being
performed in a “state of
control”.
The key aspect of this approach is the organization and control
of all types of project
information in a manner that ensures
information flows sequentially through each project
phase while
maintaining a “state of control” with all required information accounted for
without
re-creating or repeating information.
Master level
documents describe required procedures, information, and format in order to
assure orderly linkage to the other project activities and control all
activities of each project
phase. Overall requirements and
procedures of each specific project phase are contained in
the master
level documents.
Control level documents capture project specific
information in detail. Project information and
requirements are
captured in a consistent set of templates that flow through the project life
cycle in a consistent and controlled manner.
Project phases addressed by the
operating system include:
- Definition
- Engineering
- Construction
- Commissioning
- Qualification
- Process
validation
- Operations
Goals- The GMP CB OS strives
to:
- Provide a "Road-map"
for project execution
- Organize engineering
execution to provide streamlined input to C & Q efforts
- Integrate
Commissioning and Qualification efforts from the outset of a
project
- Increase Compliance
and quality of the associated documentation
- Capture and retain
intellectual knowledge in order to improve project execution
