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GAMP 5

Risk based approach to the GxP computer system validation

The leading international source of guidance


on computer systems validation and compliance

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GAMP History

 First draft - Feb, 1994 - Distributed UK industry for comments


 Second draft - Jan, 1995 - Incorporating comments from 31
companies
 Version 1.0 - Mar, 1995 - Electronic Version only
 Version 2.0 - May, 1996 - incorporating comments form Europe
and USA
 Version 3.0 - Mar, 1998 - Separation in to User and Supplier
 Version 4.0 - Dec, 2001 - Major Revision
 Version 5.0 - Feb, 2008 - Risk based approach to GxP regulated
computer systems
 GAMP4 is 7 years old

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Introduction

GAMP has been a part of ISPE for a decade

GAMP is leading Community Of Practice (COP)

GAMP is Part of bigger ISPE Body of Knowledge

Acceptance of GAMP Guidance by regulators


worldwide

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Objective

To achieve computerized systems that are fit for


intended use and meet current regulatory
requirements, by building upon existing industry
goes practice in an efficient and effective manner

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Objective is on

Patient Safety

Product Quality

Data Integrity

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Scope

All GxP Computerized Systems

Operational Guidance for

 IT
 Labs
 Manufacturing
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GAMP Document Structure

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Management Appendices
 Appendix M1 Validation Planning
 Appendix M2 Supplier Assessment
 Appendix M3 Science Based Quality Risk Management
 Appendix M4 Categories Of Software and Hardware
 Appendix M5 Design Review and Traceability
 Appendix M6 Supplier Quality and Project Planning
 Appendix M7 Validation Reporting
 Appendix M8 Project Change and Configuration Mgmt.
 Appendix M9 Document Management
 Appendix M10 System Retirement

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Development Appendices
 Appendix D1 User Requirement Specifications
 Appendix D2 Functional Specifications
 Appendix D3 Configuration and Design
 Appendix D4 Management, Development, and Review
of Software
 Appendix D5 Testing of Computerized Systems
 Appendix D6 System Descriptions
 Appendix D7 Data Migration

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Operation Appendices
 Appendix O1 Handover
 Appendix O2 Establishing and managing support services
 Appendix O3 Performance Monitoring
 Appendix O4 Incident Management
 Appendix O5 Corrective and Preventive Action
 Appendix O6 Operational Change and Configuration
Management
 Appendix O7 Repair activity
 Appendix O8 Periodic Review
 Appendix O9 Backup and Restore

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Operation Appendices
 Appendix O1 Business Continuity Management
 Appendix O11 Functional Specifications
 Appendix O12 Configuration And Design
 Appendix O13 Archiving and Retrieval

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Special Interest Topics Appendices
 Appendix S1 Alignment with ASTM E2500
 Appendix S2 Electronic Production Records(EPR)
 Appendix S3 End User Applications Including
Spreadsheets
 Appendix S4 Managing Quality within an Outsourced
IS/IT Environment
 Appendix S5 Organizational Change

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General Appendices
 Appendix G1 GAMP Good Practices Guide Summary
 Appendix G2 Glossary and Acronyms
 Appendix G3 References

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GAMP 5 Categories

Five Categories defined by GAMP


Analyze and categorize software and hardware
components of a system
Used with
Risk Assessment
Supplier Assessment
To determine a suitable life cycle strategy
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GAMP Categories
Category GAMP4 GAMP5

1 Operating System Infrastructure software


2 Firmware No longer used
3 Standard software Non-configured
packages products
4 Configurable Configured products
software packages
5 Custom (bespoke) Custom applications
software
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Category 1 –Infrastructure software

Operating System and Associated system software

Commercially available layered software

Infrastructure software tools

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Category 3 –Non-configured Products

Non-configurable

Default configuration used

Simplified life cycle, e.g

URS
Single test phase

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Category 3 –Example

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Category 4 –Configured Products

Standard interfaces and functions

Configuration for user specific processes

Verify …

Requirements

Functionality
Configuration
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Category 4 –Example

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Category 5 –Custom Applications

Meet Specific Needs

Comprehensive life cycle e.g..


URS
FS
Design /Config. Spec
Several Levels of Testing
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Category 5 –Example

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Hardware Categories

Hardware Category 1 -Standard


Document details and verification of installation
and connection

Hardware Category 2 - Custom


Design and acceptance testing
Supplier Audit may be required

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Category 5 –Custom Applications

Meet Specific Needs

Comprehensive life cycle e.g..


URS
FS
Design /Configuration Spec
Several Levels of Testing
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GAMP 5 Key Concepts

Five key concepts, based on current and innovative


industry thinking underpin the rest of the document

Life Cycle approach within a QMS


Scalable Life Cycle Activities
Process and Product Understanding
Science-Based Quality Risk Management
Leveraging Supplier Involvement
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GAMP 5 Key Concepts

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Process and Product Understanding

Basis of Science-and risk based decisions


Focus on critical aspects

Identity
Specify
Verify
CQAs/CPPs (Crital Quality Attributes, Critical Process Parameters)
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Life cycle Approach within a QMS

Suitable Life Cycle


Intrinsic to QMS
Continuous improvement

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Life cycle Approach within a QMS

 A life cycle approach entails defining and performing


activates in a systematic way from conception,
understanding the requirements, through development,
release, and operational use, to system retirement

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Scalability Life Cycle Activities

Scalability is based on…

Risk
Complexity

Supplier

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Stages within the Project Phase

Planning
Specification, configuration, and coding
verification
Reporting and release

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Specification and Verification
 ASTM E2500 Standard Guide for specification, design, and
verification of pharmaceutical and biopharmaceutical
Manufacturing Systems and Equipment

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Specification and Verification

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GAMP 5 - Good Automated Manufacturing Practices
Computer system Validation Framework

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Planning

 Activities
 Responsibilities
 Procedures
 Timelines

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Reporting and Releasing

• Handover

 Project Team

 Process Owner
 System Owner
 SMEs
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 Operational user Aurobindo Pharma
GAMP 5 - Good Automated Manufacturing Practices
Science Based Quality Risk Management

Assessment
Control
Communication
Review

Focus on Patient safety


Product quality

And data integrity

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