1. GAMP - Process Control SIG
GAMP 4 + Beyond
Tony de Claire

2. 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

3. 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)

4. 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)

5. 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)

6. 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

7. 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

8. 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

9. 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 )

10. Planning & Definition Define Scope Software Hardware Instrumentation
Electrical
Mechanical

11. Planning (continued) Supplier Assessment Quality and Project Plan
Quality System
Capability
Audits
Quality and Project Plan
Define structure of lifecycle documents
GxP Criticality and Compliance Risk Assessment

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. Design Specifications
Specifications for system design:
Software
Hardware
Instrumentation
………… may include mechanical and electrical general arrangement drawings

19. 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

20. 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

21. Detailed Design Documentation
Interconnection Drawings
Connections to field instrumentation
Wiring termination, identification, rating, and polarity
Sufficient detail to enable assembly, installation, and fault diagnosis

22. Hardware Design Specification
Defines architecture and configuration of the hardware, including:
Controllers
PCs
Input / Output types & allocation
System Interfaces

23. 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

24. 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

25. 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

26. 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)

27. 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

28. 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

29. 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”

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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”

41. 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

42. 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

43. 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

44. GAMP Liaison
Thanks to
Sion Wyn & John Andrews

45. Any Questions?
Tony de Claire
Process Control SIG