ISPE SFChGAMP

Good Automated Manufacturing Practices (GAMP)
Klaus Krause, Amgen

ISPE/GAMP Americas Steering Committee
ISPE San Francisco/Bay Area Chapter Meeting, October 7, 2004
10/7/2004
[email protected]
Presentation Overview
I. GAMP - Organization and Objectives II. GAMP4 Guide for Validation of Automated Systems
10/7/2004
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Part 1
GAMP Organization and Objectives
10/7/2004
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Pivotal Inspection
Before Validation Plan IQ OQ PQ Validation Report
10/7/2004 [email protected]
After Additionally: Specification Design Review (DQ) Source Code Review Supplier Audit
GAMP Objectives
Achieve Compliance by building upon existing industry good practices in an effective and efficient manner
10/7/2004
[email protected]
GAMP Forum
Industry Board European Steering Committee GAMP Council Americas Steering Committee Local ISPE
Special Interest Groups (SIGs)
10/7/2004
[email protected]
GAMP Council
Technical Sub-Committee of ISPE
Set Directions Influence Industry and Regulators on the Interpretation of Regulations pertaining to:

Information Systems Control Systems Laboratory Systems
10/7/2004
[email protected]
GAMP Organizations
GAMP Europe GAMP Japan
JETT
GAMP DACH
Supplier SupplierForum Forum
GAMP Americas

Laboratory Systems IT Infrastructure Qualification Manufacturing Execution Systems Electronic Data Archiving Global Information Systems Research and Development Systems

Building Management Systems Testing of GxP Critical Systems JETT Consortium
10/7/2004
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Organizational Links
APV (Germany) GMA/NAMUR (Germany) JETT ISPE
10/7/2004
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Links to Regulatory Agencies

FDA MCA European Union
10/7/2004
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Influence
Established reference in UK/Europe Cited by regulators as baseline practice by regulators (inc. FDA and MCA) Training of FDA Inspectors
10/7/2004
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GAMP Good Practices Guides

GAMP4 Validation of Automated Systems Calibration Management Validation of Process Control Systems Validation of Legacy Systems
10/7/2004
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In Preparation Validation of Laboratory Systems IT Infrastructure Qualification Validation of Manufacturing Control Systems (MES) Validation of Global Information Systems
10/7/2004
[email protected]

In Preparation Validation of R&D Systems Validation of Building Management Systems Testing of GxP Critical Systems Risk based Qualification of Equipment
10/7/2004
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Questions ?
10/7/2004
[email protected]
Part II
GAMP4 Guide for Validation of Automated Systems
10/7/2004
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GAMP4 Principles
Create simple, well understood rules Scale validation for size, criticality, and complexity Benefit from supplier capabilities Benefit from configurable SW packages Maintain validated state of the system in the operational environment
GAMP4 Principles
Harmonize GAMP terminology with international quality concepts and industry initiatives Collaborate with other industry groups Achieve greater awareness of GAMP internationally
10/7/2004
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Structure of GAMP4 Guidance

GAMP4 Guide is main body Good Practices Guides are supplements to GAMP4 Guide Guidance follows validation life cycle GxP Compliance Solutions for System Users and Suppliers
10/7/2004
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Structure of GAMP4 Guide

GAMP Principles and Framework
Appendices Management Development Operation
10/7/2004
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GAMP4 Themes
System Development Life Cycle Validation Planning Risk and Impact Assessment Supplier Quality Management Specifications Design Review Formal Testing/Verification
[email protected]
10/7/2004
Automated System
Environment: Legal, Organizational, Physical, Technical
Documentation Equipment, Instruments Computer Hardware System Software Data Application SW
Used together for a given task

GAMP4 Software Categories

1 - Operating Systems 2 - Firmware 3 - Standard Software Packages 4 - Configurable Software Package 5 - Custom Software
10/7/2004
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GAMP4 Life Cycle

User Requirements Specifications related to Performance Qualification
Functional Specifications
related to
Operational Qualification
Design Specifications
related to
Installation Qualification
System Build
10/7/2004
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System Verification & Validation

System User Requirements
Sys. Req.
Supplier
Hardware
Software
Data
0101 0110 1010 1011 0101 1101 0101 0110
QMS
Design Review
Audit Report
Qualific. Protocol
Test Report
Verification Protocol
Review Protocol
10/7/2004
Validation Summary [email protected] Report
Management of the Validation

Validation Planning Supplier Audit Risk Assessment Categories of Software and Hardware Design Review and Traceability Matrix Quality and Project Planning Document Management Project Change Control Validation Reporting
[email protected]
10/7/2004
Validation Planning
Strategy Deliverables Responsibilities Standards and Procedures
Formally approved Plan

System Categorization
Many systems contain software components of more than one category:

Operating System Configurable application Firmware Custom modules
10/7/2004
[email protected]
Supplier Assessment
Guidance and tools on:

Assessment of capabilities and product Audits Management
10/7/2004
[email protected]
User Supplier Relationship

Primary Responsible for Specification
User
User Requirements Specification Testing of the URS
Primary Responsible for Testing

Performance Qualification System Acceptance Testing System Acceptance Testing (Operational Qualification (Operational Qualification of Computer/PLC) of Computer/PLC)
User
Functional Specification
Testing of the Functional Specification
User and Supplier
User and Supplier

Software Design Software Design Specification Specification Software Module Software Module Specification Specification Hardware Design Specification
Hardware Acceptance Testing Testing of the Hardware Acceptance Testing (Installation Qualification Hardware Specification (Installation Qualification of Computer/PLC) of Computer/PLC) Software Integration Software Integration Testing Testing
Supplier Supplier
Software Module Testing Software Module Testing Review and Test Modules
Code Modules Code Modules
10/7/2004
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Validation Strategy
Based on: Risk Assessment Assessment and Categorization of System Components Supplier Assessment
10/7/2004
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Risk and Impact Assessment

Identify Processes Analyze:

Risk scenarios Effects for each event Likelihood of events Severity of Impact Likelihood of Detection
Plan for Risk Management

Validation Activities
Planning Specification Test Planning IQ, OQ, PQ Testing IQ, OQ, PQ Review
10/7/2004
Prepare written Validation Plan. Specify and agree what is required. Perform Design Reviews Prepare document to describe how the equipment or system is to be tested. Perform tests and collect results. Review results to show .. that the system performs as specified, report conclusions plus any reservations
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Validation Approach
Category 1: Operating System Record version (incl. Service pack) Challenge OS indirectly by the functional
10/7/2004
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Validation Approach
Category 2: Firmware (Off-the-Shelf) IQ: Verify name, version, configuration, and
Change Control for firmware and configuration parameters Supplier Audit for complex or critical applications
calibration OQ: Test functionality
Validation Approach
Category 3: Standard Software Packages Configuration limited to the environment and
parameters IQ verifies name and version OQ tests user requirements Supplier Audit for critical applications
10/7/2004
[email protected]
Validation Approach
Category 4: Configurable Software Packages
Treat like Category 5 if platform and package not mature and well-known
10/7/2004
[email protected]
Validation Approach
Category 5: Custom Software Execute complete Validation Life Cycle
10/7/2004
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Qualification Approach
Category 1: Standard Hardware Component Record Model, Version, Serial number of preassembled hardware Verify installation and Connections Use hardware data sheet or other specifications for information on sealed units Apply change control and configuration management
Qualification Approach
Category 2: Custom Built Hardware Same as Category 1, plus:

Design Specifications with configuration Acceptance Testing Supplier Audit of development process Verification of Compatibility for components from different Sources Verification at IQ
[email protected]
10/7/2004
System Development
Build System and Achieve Validated State
User Requirement Specification Functional Specification Hardware Design Specification Software Design Specification Production, Control, and Review of Software Testing of Automated System
System Specifications
Define the System Allow further Specifications to be developed Allow the System to be developed Allow Maintenance of the System
10/7/2004
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Design Review (1)

Evaluate Deliverables against Standards and requirements Identify problems and propose corrective actions
10/7/2004
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Design Review (2)

Are all Requirements addressed? Is functionality appropriate and consistent? Will the system meet predefined standards? Is system appropriately tested?
10/7/2004
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Requirements Traceability
Forward and backward traceability: System Requirements Design Test
10/7/2004
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Traceability Matrix
URS Ref Description GxP? Other? FS Ref DS Ref Test Ref (IQ, OQ, PQ, FAT, SAT)
1.0 2.0 2.1 2.2
Text.. Text Text Text
Y Y N N
Y N Y N
FS02 3.1.4 FS02 4.2.5
DS_DOC1 4.5 DS_DOC1 6.2
SATEST3 7.8 SATEST3 9.6
10/7/2004
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Software Control
Module Traceability and Identification Design and Documentation Principles Good Programming Practice Source Code Review
10/7/2004
[email protected]
Testing of Systems
Test Planning, Specification, Execution, Documentation Scope of Testing Test Specifications Test Deliverables Good Practices for Testing
10/7/2004
[email protected]
System Operation
Maintain Validated State

Periodic Review Service Level Agreement Automated System Security Operational Change Control Performance Monitoring Record Retention, Archive, and Retrieval Backup and Recovery of Software and Data Business Continuity Planning
[email protected]
10/7/2004
GAMP4 Recap
GxP Computer Compliance Solutions Integration of Quality Standards (ISO9000) and Industry Standards (IEEE) Consensus of Regulators, Life Science Industry, and Consultants
10/7/2004
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Acknowledgments
Dr. David Selby, Selby Hope International Sion Wyn, Conformity Arthur Perez, PhD, Novartis
10/7/2004
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Questions ?
10/7/2004
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Thank You
for your Interest in GAMP
10/7/2004
[email protected]

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Good Automated Manufacturing Practices (GAMP)

Klaus Krause, Amgen

ISPE San Francisco/Bay Area Chapter Meeting, October 7, 2004

Special Interest Groups (SIGs)

Technical Sub-Committee of ISPE

Information Systems Control Systems Laboratory Systems

Supplier SupplierForum Forum

Special Interest Groups (SIGs)

Special Interest Groups (SIGs)

Links to Regulatory Agencies

GAMP Good Practices Guides

GAMP Good Practices Guides

GAMP Good Practices Guides

Structure of GAMP4 Guidance

Structure of GAMP4 Guide

Used together for a given task

GAMP4 Software Categories

GAMP4 Life Cycle

System Verification & Validation

Validation Summary [email protected] Report

Management of the Validation

Formally approved Plan

Operating System Configurable application Firmware Custom modules

Assessment of capabilities and product Audits Management

User Supplier Relationship

Primary Responsible for Testing

Testing of the Functional Specification

User and Supplier

User and Supplier

Code Modules Code Modules

Risk and Impact Assessment

Plan for Risk Management

calibration OQ: Test functionality

Design Review (1)

Design Review (2)

1.0 2.0 2.1 2.2

Text.. Text Text Text

FS02 3.1.4 FS02 4.2.5

DS_DOC1 4.5 DS_DOC1 6.2

SATEST3 7.8 SATEST3 9.6

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