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
………… 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?