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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 System
� Capability
� Audits
� Quality and Project Plan � 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
BBBB 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 user-site
� 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, walk-
through etc) by independent developer(s)
� Examined against formal procedures prior to
testing
� Ensure written / configured against pre-
defined 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
Tony de Claire
Process Control SIG
Any Questions?