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GAMP - Process Control SIG
GAMP 4 + Beyond
Tony de Claire
GAMP - Process Control SIG
SIG Background
Evolved from impromptu lunchtime meeting at the launch of
initial GAMP (PICSVF) draft release in Westminster
Two control engineering representatives given a mission at a
meeting hosted by Wellcome, Dartford soon after
Initial Group set up, with recruitment at a hotel bar in Basle
(May’96)
Group’s basic aim is to “voice” control system issues
Well attended group with members of “user” background
Active with / instigating a variety of contributor panels
GAMP - Process Control SIG
Purpose:
Address the considerations in applying GAMP Principles to
Process Control System applications
Work focus:
Process Control Systems Section in GAMP 4 *
Forthcoming GAMP “Good Practice Guide”
Input to Calibration panel, Audit, GEP revisions
Liaison with NAMUR and JETT
( * copies of pre-edited Draft available)
GAMP 4 - Process Control Systems
Used to automate manufacturing processes
Dynamic real-time I/O
Collect data
Control and manage the process
Link to higher level data handling functionality or
systems in Computer Integrated Manufacturing
(CIM)
GAMP 4 - Process Control Systems
Covers a wide range of systems
Small control systems, e.g. in manufacturing
equipment
Large control systems, e.g. operating bulk product
plants
Two Main Categories
Embedded
Standalone (Integrated)
Embedded Systems
Microprocessor, PLC, or PC with sole purpose
of controlling / monitoring manufacturing
equipment.
Usually delivered ‘embedded’ in a unit or
machine
Multi-discipline engineering effort required to
produce
Much of the lifecycle documentation produced
by supplier
Standalone Systems
Self contained systems, usually delivered
separately & connected to field devices
May be linked to / provide higher level
functionality
Supervisory Control and Data Acquisition
(SCADA)
Distributed Control Systems (DCS)
Controller or PLC controlling part of a process
Project engineering and co-ordination
required
GAMP Validation Principles
Lifecycle (ref. Draft Figs 3.3, 3.4, 3.5)
Planning, Supplier and Compliance Risk
Assessments
User and Supplier Partnership
Specifications
Traceability
Formal Testing and Verification
Documented Evidence
Lifecycle Phases
Planning & Requirement Definition
Design Specification, System Development, &
Build
Design Review and Acceptance Testing
Qualification & GEP Commissioning *
Operation and Maintenance
Decommissioning and Retirement
( * Aligns with ISPE Baseline Guide for Commissioning &
Qualification )
Planning & Definition
Define Scope
Software
Hardware
Instrumentation
Electrical
Mechanical
Planning (continued)
Supplier Assessment
Quality and Project Plan
Quality System
Capability
Audits
Define structure of lifecycle documents
GxP Criticality and Compliance Risk
Assessment
Importance of Specifications
Provide a structured definition of system
requirements
Enable requirement traceability matrix
Allow complimentary lifecycle documents to
be developed
Support focused and auditable system
development
Establish test acceptance criteria
Support maintenance of the system
User Requirements Specification
For small embedded applications, could be
part of equipment specification
For large standalone applications, e.g. DCS
or SCADA, a separate URS is normal
User Requirements Specification
URS to clearly identify:
Parameters to be controlled and monitored
Data to be generated, manipulated, or stored
Functions to be performed
Process sequence, interlocks, alarms
Quality-related critical parameters, data &
functions
Safety and Environmental requirements
Levels of testing required
Functional Specification
Embedded System – FS may be part of overall
equipment specifications, including instrument,
electrical, and mechanical elements
Standalone System – FS typically one document,
identifying the functions, features and the design
intentions for the system hardware and software
Functional Specification
Establishes how the requirements of the URS
will be implemented
Functions to be performed
Facilities to be provided
Detailed process sequence logic and interlocks
Interfaces to instruments, equipment, and other
systems
Normally produced by supplier in response to
the URS
Functional Specification
Basis of subsequent testing and verification,
e.g. System Acceptance Testing
Divergence with the URS to be identified
Should identify any software functions that
are not being utilised
Often a contractual document subject to
Change Control by Supplier
Design Specifications
Specifications for system design:
Software
Hardware
Instrumentation
………… may include mechanical and electrical general
arrangement drawings
Detailed Design Documentation
Process and Instrument Diagrams (P&IDs)
Showing process flow
Identification and location of associated control
and monitoring loops
Plant Equipment Layout
Identification and location of major items
Detailed Design Documentation
Loop and Instrument Schedule
Identify items in the loops
Measurement ranges and tolerances
Inputs and output signals
Identifies Critical Parameters
Alarm trip points and actions
Sequence Logic & Interlock details
Detailed Design Documentation
Interconnection Drawings
Connections to field instrumentation
Wiring termination, identification, rating, and
polarity
Sufficient detail to enable assembly, installation,
and fault diagnosis
Hardware Design Specification
Defines architecture and configuration of the
hardware, including:
Controllers
PCs
Input / Output types & allocation
System Interfaces
Software Design Specification
Defines how the software is to implement the
Functions Specification
Defines the software and data structure,
architecture, the software modules, their
interactions, and interfaces.
Structural modular programming language /
techniques
Software Design Specification
Should identify programming standards
where coding is involved, and naming
conventions in all cases
Ensure “annotated” hardcopy of software
software provides clear understanding and
can be used testing aid
All non-standard software to be identified
System Software Development
Against pre-defined design intentions
In accordance with suitable structured
programming standards
Author fully conversant with programming
language / techniques
Author experienced in similar design
intentions
System Build
Embedded System - usually final assembly into
automated equipment precedes installation at usersite
Standalone System – the computer system &
instrumentation are shipped to site, inspected and
installed in conjunction with the manufacturing /
process equipment
(All system build carried out according to approved
manufacturer design/assembly documentation)
Software Review
Software to be reviewed (inspection, walkthrough etc) by independent developer(s)
Examined against formal procedures prior to
testing
Ensure written / configured against predefined intentions and in accordance with
programming standards
Design (& Development) Review
Formal and systematic verification that
specified requirements are covered by the
design and development activities
Supported by a structured set of lifecycle documentation
May be a series of reviews throughout system design and
development
To verify adherence to Requirements Traceability Matrix
Can encompass elements of “acceptance testing”
Requirements and Design intentions should be agreed
before significant code development
Findings to be documented in a Design Review Report
Acceptance Testing
Proving the correct operation of software,
hardware, and instrumentation, as defined by
the URS and FS
Based on approved Test Specifications, and
formally reported
Test specifications to include objectives,
procedures and “acceptance criteria”
To focus on GxP and other critical functions
and data
Determine level of testing to support Lifecycle
“Qualifications”
Acceptance Testing
Depending on circumstances can encompass
system development / build testing:
Software development tests
Hardware manufacturing tests
System integration tests
Instrument manufacturing / calibration tests
SAT (and FAT)
Tests during & on completion of manufacture
to be to pre-defined procedures and
documented
Acceptance Testing
Factory Acceptance Testing (FAT)
Pre-delivery
Normally a “contractual milestone”
For standalone systems - without connection to
field instrumentation, with an agreed level of
process simulation
Testing constraints to be documented
Opportunity to identify problems best resolved in
Supplier environment
Acceptance Testing
Site Acceptance Testing
To determine that the system and any associated
equipment has not been damaged, and functions
correctly in the operating environment
Normally a repeat of the FAT plus tests possible with
process, instrumentation, interfaces, and service
connections in place
With adequate level of test procedures may be
combined with engineering commissioning to provide
necessary test data for IQ and OQ
Calibration of Instrumentation
Pre- and post-delivery, to defined, approved
procedures
Test equipment documented, and traceable
back to acceptable standards
Calibration test results retained
Establish calibration interval depending on
criticality, robustness, sensitivity, and
operational experience
Qualification
Installation Qualification (IQ) confirms:
Hardware, electrical connections, data highways,
field instrumentation, field cabling (and
associated electrical & pneumatic equipment) is
installed to documented design / standards
Software loaded correctly
Basic system functions operate satisfactorily on
power-up
System configuration / calibration
Field instrumentation calibrated
Lifecycle and associated support documentation
approved and available
Qualification
Operational Qualification (OQ) - confirms that
operation of system hardware, software, I/O devices
and field instrumentation will function satisfactorily
under normal operating conditions and, where
appropriate, under realistic stress conditions
Performance Qualification (PQ) - normally
carried out in conjunction with process qualification to
confirm the correct operation of all system
components, associated equipment, people and
procedures that combine to run the manufacturing
process
Validation
Qualification / Validation Reports – on
successful completion of qualification testing and
approved summary reports, a Validation Report will
confirm that the system is ready for use in the
manufacturing process for which it was designed
Operation & Maintenance
To ensure validation status is maintained:
Quality, Maintenance and Calibration regime
Configuration Management
Change Control
Reference to critical process parameters / data
and Requirements Traceability Matrix
Periodic Reviews and Internal Audits
System reliability, repeatability, performance &
diagnostic data
Approved Lifecycle document status and
accuracy
SOP status and use
System Retirement
Decommissioning to include archiving data
and software
Archive Report to describe approach, list
documents, raw data, and electronic records
Verification of critical instrument calibration
Special care with preservation and
availability of GxP records throughout their
retention period, as required by of 21 CFR
Part 11, and associated predicate rules
Conclusions
GAMP Principles - can be applied effectively
to process control systems, both embedded
and standalone
Good Engineering Practice - normal
engineering commissioning activities can
support the requirements of Qualification
testing
GAMP – Process Control SIG
Q. What’s next?
A. Produce a Good Practice Guide
Work underway to expand on the work done
for the new GAMP 4 publication and produce
a supplementary Good Practice Guide for
“Validation of Process Control Systems”
Validation of Process Control
Systems Guide
Proposed Contents
Introduction, Background, Definitions
Regulatory Considerations
Supplier Assessments
Standalone and Embedded Systems
Importance of Good Specifications
Manufacturing Parameters & Quality Data
Lifecycle of Process Control Systems
Criticality Assessment
Systems Specification, Design, Development and
Review
Validation of Process Control
Systems Guide
Proposed Contents (continued)
Factory Acceptance Tests
Installation Qualification
Operational Qualification
Maintenance
Calibration
Change Management
Review of Existing Systems
Retirement / De-commissioning
New Technologies
Validation of Process Control
Systems Guide
Proposed Contents (continued)
Appendices
Critical Parameters & Data
Software Categories for Control Systems
Postal Audit of Suppliers
NAMUR guidance documents
GAMP Liaison
Thanks to
Sion Wyn & John Andrews
Any Questions?
Tony de Claire
Process Control SIG