GAMP/JETT AGENDA
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Introduction and GAMP Organization
GAMP Process Control Supplement
Benefits of the GAMP/JETT
Methodology
Working Session
Questions & Answers
Dale Noteboom
Jim John
Chris Roerig
JETT Team
JETT Team
GAMP Forum Developments
~ 12 Special Interest Groups (SIG's)
 GAMP Americas established Sept 2000
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– 8 New Special Interest Groups established
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New groups incorporated into GAMP
Forum
– North American JETT Consortium joined
(2000)
– UK Suppliers Forum joining (2001)
GAMP Forum Organisation
JETT
ISPE/GAMP
APV
Namur Group
Supplier Forum
GAMP Americas
GAMP Europe
Executive Summary of
Good Automated
Manufacturing Practice
(GAMP) Guide

GAMP Scope: “Automated
Systems”
Consist of:
Hardware
- Controlled Functions
– Software
- Network Components
– Associated Documentation
Applies to:
– Automated Manufacturing Equipment
– Control Systems
– Automated Laboratory Systems
– Manufacturing Execution Systems
– Computers Running Manufacturing or Laboratory
Databases
–
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GAMP Purpose
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“Help suppliers of automated systems
to the pharmaceutical industry ensure
that systems are developed following
good practice and to provide proper
documentary evidence that their
systems meet the agreed
specifications.”
GAMP Qualification Plan
A Basic Framework for Specification, Design and Testing
USER REQUIREMENT
SPECIFICATION
Verifies
FUNCTIONAL
SPECIFICATION
Verifies
DESIGN
SPECIFICATION
Verifies
SYSTEM
BUILD
GAMP 4.0 Figure 6.2
PERFORMANCE
QUALIFICATION
OPERATIONAL
QUALIFICATION
INSTALLATION
QUALIFICATION
Part 1: User Responsibilities

Validation (Master) Plan & System
Specific Validation Plan(s)
–
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Supplier Audit
–
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Appendix 7
User Requirements Specification
–
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Appendix 6
Appendix 5
Supplier Education
New Edition: GAMP 4
Strategic Framework
Quality Management Procedures
Practical Guidance (Good Practice)
Training/Materials Workshop
GAMP 4 Goals
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Software categories developed further
Validation needs to be scaleable
Global acceptance
Examine the balance of work conducted by
pharmaceutical manufacturers and their
suppliers.
Harmonization of terminology with other
industry forums.
Best Practice Guides

First Wave
–
–
–
–
Calibration
IT Infrastructure: Networks, Desktop,
Harmonized Terminology
Electronic Records and Signatures
Additional Planned Guides
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Second Wave
– Control Systems: including Standalone PLC/SCADA/DCS and
Packaged Systems”/”Skid Mount
Equipment”
– Supplier Management
– Analytical Laboratory Equipment
– Global Systems: ERP, MRPII, LIMS,
EDMS
Additional Planned Guides
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Third Wave
–
–
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Legacy Systems
Clinical Systems
Medical Devices
E-Applications: Web-based software
Manufacturing Execution Systems
GAMP Summary
International guideline.
 Good starter system.
 Continuing to evolve (GAMP4)
 Basis for Regulatory Agency Training
and expectations
 Good “common ground” for CSV
International Alignment
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Joint Equipment Transition
Team
(www.JETTconsortium.com)
Mission Statement

Improve communications between
Users and Suppliers to more
effectively meet the “validation”
requirements of the pharmaceutical
industry.
JETT MEMBERS
USER Representatives
•
•
•
•
•
•
Abbott Labs – Tim Schuetter
Pharmacia - Dale Noteboom
Eli Lilly - Bret Fisk
Aventis Behring – John Dexter
Aventis Pasteur – Jeff O’Donel
Perrigo – Paul Coury
SUPPLIER Representatives
•
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Fisher-Rosemount – Jon Lustri
Bosch /TL Systems - Terry Petro
Vector Corp - Don Rosendale
Rockwell – McCarthy, Jiang
BOC Edwards – Mike Stella
Millipore – Ramon LeDoux
Invensys – Russell Regan
CONSULTANT Reps
•
•
•
•
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VAI Automation - Chris Roerig
Jacobs Engrg – Brokamp, Buede
PV - Filary, Rivera, Lauderman
PAC – Bruce Lauderman
Fluor-Daniel – Mike Humphries
BE&K Engr – Vince Miller
Brock Solutions – John, Casey
~ 14 Active Members
+ 45 Assoc. Members & Growing
JETT BASELINE EXAMPLE
User Requirement Specification
 Project Planning
 Functional & Design Specifications
 Acceptance Tests
- Hardware - System
- Software
- Factory
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JETT EQUIPMENT ACQUISITION MODEL
SUPPLIER
USER/(CONSULTANT if applicable)
User Audit
Master Validation Plan
Equipment Validation Plan
• Explanation to Supplier
Engineering Feasibility Study
and Results
User Requirements
Specification
(Living Document)
Proposal
• Quality & Validation Plan
Functional Specification
Proposal Analysis
(traceable to URS)
Approval
Review Functional Specification
• Project Plan
Detailed Design
Documentation
(traceable to Functional Specification)
Review Detailed
Design
System Acceptance Test
Specifications (IQ/OQ)
• Hardware
Review System
Acceptance Test Specifications
Integrate with Validation
Documentation as appropriate
• Software
System Acceptance
Testing and Results
User Witness Optional
Maintenance & Support
Documentation
JETT Efforts
Applying GAMP to Automated
Equipment
 Communicating GAMP Approach
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Interphex 1997, 2000, & 2001
ISPE - Regional & National Meetings
Pharmaceutical Online Articles
Pharmaceutical Engineering Articles
Institute of Validation Technology – Conferences
and Articles
– Published in VPCS Supplement to GAMP 4
JETT Efforts
Providing Input to GAMP Forum
 Developing Guidance for Equipment
URS’s, Equipment Validation Plans,
Functional and Design Specifications
and IQ/OQ’s
 Working directly with Industry OEM’s

JETT Efforts
Equipment Validation Plan Template
 URS Template
 Common equipment URS examples and
templates
 Baseline example for Pure Steam
Generator
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– URS, FRS, HDS, SDS, FAT
JETT Efforts
 Released
URS Documents
Glassware Washers
Vial Washer
Saturated Steam
Autoclave
Barrier Isolator & HVAC
System
Label Rewinder
Chromatography
Labeler
Multiple-Effect Still
Pure Steam Generator
JETT Efforts
 URS
Documents in development
Granulators
Centrifuge
Wide Range Filler
Tablet Press
CIP Systems
Variable Data
Inspection
Fluid Bed Dryer
Tangential Flow
Filtration System
BioReactors
Building Management
Systems
Freeze Dryer
Tablet Coater
Purified Water
System
SCADA System
Cappers
Blender
Depyrogenation
Tunnel
GAMP Process Control
Supplement
GAMP Process Control
Supplement - Purpose
“This Guide is intended is a supplement to
the GAMP Guide, and provides a
harmonized overview of the key elements
involved in the lifecycle of process control
systems, from inception to retirement. As
such, the Guide complements the current
Baseline Guide on Commissioning and
Qualification from ISPE.”
GAMP Process Control
Supplement - Scope

Systems that control the manufacturing process,
and have direct impact on product quality
attributes at any stage in the life cycle. Product
quality attributes include the identity, efficacy,
strength, dosage, quality, disposition, safety, and
purity of the product
Systems that process, transfer, or store process
information in electronic format
GAMP Process Control
Supplement - Benefits
Application and adaptation of the general principles of
GAMP 4 to process control systems
A comprehensive overview of current best practice
techniques for process control systems
Reduction of the cost and time required to achieve
compliant process control systems
Application of good practice to the development and
management of projects involving process control
systems to meet regulatory expectations
Harmonized approaches for embedded as well as
standalone systems
Detailed definition of engineering steps
GAMP Process Control
Supplement - Benefits
Detailed guidance on the generation of user requirements
specifications
Guidance on functionality and structures of process control
systems as well as supplier services required
Guidance on the supplier services required for regulated
environments
Avoids extensive and time-consuming retrospective
validation of legacy process control systems, but provides
for the application of a risk based approach, if required
Clarifies the collaboration between user and supplier
Guidance on incorporation of supplier documentation into
the user validation documentation Modified and extended
supplier audit to ensure compliance of the supplier’s
development processes and documentation
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GAMP Process Control
Supplement - Release
Global Introduction of the VPCS Guide
ISPE Washington Continuing Advancement
Conference – June 4 Arlington, VA
JETT Benefits Analysis
Chris Roerig
Benefits of JETT Approach
Provides Standards/Guidelines for
 Project Lifecycle
 Deliverables
 Documentation
 Approvals
Industry Consistency
Benefits of JETT Approach
"Speed to Market"
 Smoother Procurement Process
 Smoother Validation Process
 Shorter Project Schedule
Reduced Project Costs
 Integration Services
 Validation
 Re-work
Savings Analysis
% of Purchase Price
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User
5-6 % savings
– Gains:
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Qualification Protocol development & execution
Life Cycle support (maintenance, upgrades)
– Losses:
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Additional Auditing
Validation Plan
URS development
Time Savings
3 - 14 weeks
Savings Analysis
% of Purchase Price
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Supplier 3 - 6% savings
– Gains:
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Functional, Design, & Test spec development
System production costs
FAT
– Losses
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Supplier Audits
Time Savings 6 - 8 weeks
Savings Analysis
% of Purchase Price
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Consultant
3 - 4 % savings
– Gains:
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Functional, Design, & Test Spec Development
FAT
– Losses
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Integrator Audits
Time savings 3-10 weeks
Real World
Example
Courtesy of:
Dr. David Selby,
David Begg Associates,
Kirkbymoorside,
N. Yorks, UK
YO6 6AX
Scenario
• two equivalent sterile filling lines
• 1991 - ampoules (pre GAMP)
• 1994 - vials (post GAMP)
• equivalent equipment train
- tunnel steriliser
- filler
- automatic crack detection
- automatic particulate inspection
• equivalent project cost (~$2m)
Pre-GAMP Project
Engineering
Performance
Requirements
Specification
Minimal
0 <30%
Design Qualification
Not done
0
Pre-Delivery Inspection
0
100
60%
100
Now
7 days
0
70% 100
5 weeks
Installation Qualification 0
0 8-12%
Operational Qualification
Efficiency
(Day 1)
Availability
(for production)
100
Wastage
Software Review
Not done
Poor
Maintainability
Misc. Controls
Validation
Not done
Significant
Retrospective
Validation
Adequate
Documentation
0
Total Man days
(approx.)
100
30 days
Post-GAMP Project
Engineering
Requirements
Specification
Comprehensive - 2 weeks
(+ several consultations)
Design Qualification
Significant
0
7 days
Performance
0
75% 100
0
90%100
Now
Pre-Delivery Inspection
0
(for production)
0 1%
Operational Qualification
Software Review
Misc. Controls
Validation
Total Man days
(approx.)
100 Availability
5 weeks
Installation Qualification 0
Efficiency
(Day 1)
100
Wastage
4 days
Good
Maintainability
2 weeks
Unnecessary
Retrospective
Validation
Good
Documentation
0
100
90 days
Summary
To derive benefit when validating
automated systems :post GAMP
• adopt “good engineering practices”
• adopt the common approach (GAMP)
• manage the benefits through
• measure them
0
75%
0
90%
0
100%
0 1%
How Do I Get Started?
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JETT Web Site
– www.jettconsortium.com
GAMP Web Site
 Contact JETT Members for Help
 Start with Baseline Piece of Equip.
 Promote with Users, QA, & Suppliers
 Integrate in your Stds and Methods
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Working Session
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Break into functional groups
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QA/Validation
Manufacturing/Operations
Environmental/Safety/Utilities/Maintenance
Engineering
Select a piece of OEM equipment (simple)
Develop portions of a URS
Develop portions of project validation plan
URS Guidelines
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Each statement:
– Uniquely referenced
– Less than 250 words
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Express requirements, not design solution
Each requirement should be testable
URS should be understandable by user and
supplier
– No ambiguity
– No contradictions

Distinguish between mandatory and
desirable items/requirements
URS Content Checklist

Functions required
 Product requirement
 Functional requirement
 Design requirement
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Modes of operation
Performance and timing
Failure actions
 Hardware
 Software
URS Content Checklist
Safety and security
 Data
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Archive
Capacity
Speed
Definition of data and valid ranges
Interfaces
 Environment
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URS Constraints
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Schedule
Compatibility with existing networks,
hardware, etc.
Reliability requirements
Legal issues, working methods, user skill
levels, etc.
Maintenance
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Ease of maintenance
Expansion capability
Expected lifetime
Long-term support
URS Lifecycle
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Development – e.g. project
management/QA/mandatory design
methods
Testing
– Special testing under load conditions
– Test data
– Simulations
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Delivery
– Shipment directions
– Documents – what supplier is expected to deliver
URS Lifecycle
Tools
 Training
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– Engineering
– Operations
– Maintenance
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Support from vendor after:
– FAT
– Validation complete