Jett in Terp Hex 2003

GAMP/JETT AGENDA
Introduction and GAMP Organization

Dale
Noteboom
GAMP Process Control Supplement
Jim John
Benefits of the GAMP/JETT
Chris Roerig
Methodology
Working Session JETT Team
Questions & Answers
JETT Team
GAMP Forum Developments

~ 12 Special Interest Groups (SIG's)
GAMP Americas established Sept 2000
8 New Special Interest Groups established
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
Supplier Forum
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
GAMP Purpose
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)
Supplier Audit
Appendix 7
User Requirements Specification
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
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
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
Third Wave
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
Joint Equipment
Transition Team
(www.JETTconsortium.c
om)
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
CONSULTANT Reps
VAI Automation - Chris

Pharmacia - Dale Noteboom
Roerig
Eli Lilly - Bret Fisk
Jacobs Engrg Brokamp,
Aventis Behring John
Buede
Dexter
PV - Filary, Rivera,
Aventis Pasteur Jeff
Lauderman
ODonel
PAC Bruce Lauderman
Perrigo Paul Coury
Fluor-Daniel Mike
SUPPLIER
Humphries
Representatives
BE&K Engr Vince Miller
Fisher-Rosemount Jon
Brock Solutions John,
Lustri
Casey
Bosch /TL Systems - Terry
Petro
JETT BASELINE EXAMPLE

User Requirement Specification
Project Planning
Functional & Design
Specifications
Acceptance Tests
- Hardware - System
- Software - Factory
JETT EQUIPMENT ACQUISITION MODEL

SUPPLIER
USER/(CONSULTANT if applicable)
Master Validation Plan
Equipment Validation Plan
Explanation to Supplier
User Requirements
Specification
(Living Document)
Proposal Analysis
User Audit
Engineering Feasibility Study
and Results
P.O.
RF
Q al
p os
Pro
P.O.
Proposal
Quality & Validation Plan
Project Plan
Functional Specification
(traceable to URS)
Approval
Review Functional Specification
Detailed Design
Documentation
(traceable to Functional Specification)
Review Detailed
Design
Review System
Acceptance Test Specifications
Integrate with Validation
Documentation as appropriate
Approval
System Acceptance Test

Specifications (IQ/OQ)
Hardware
Approv
al
Software
System Acceptance
Testing and Results
User Witness Optional
Maintenance & Support
Documentation
JETT Efforts
Applying GAMP to Automated
Equipment
Communicating GAMP Approach
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 URSs, Equipment
Validation Plans, Functional and
Design Specifications and IQ/OQs
Working directly with Industry
OEMs
JETT Efforts
Equipment Validation Plan Template
URS Template
Common equipment URS examples
and templates
Baseline example for Pure Steam
Generator
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
Pure Steam Generator
Multiple-Effect Still
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

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.

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

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
Reduction of the cost and time required to achieve compliant
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

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 suppliers development processes and
documentation

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
User
5-6 % savings
Gains:
Qualification Protocol development & execution

Life Cycle support (maintenance, upgrades)
Losses:
Additional Auditing
Validation Plan
URS development
Time Savings
3 - 14 weeks
Savings Analysis
% of Purchase Price
Supplier
3 - 6% savings
Gains:
Functional, Design, & Test spec development

System production costs
FAT
Losses
Supplier Audits
Time Savings 6 - 8 weeks
Savings Analysis
% of Purchase Price
Consultant
3 - 4 % savings
Gains:
Functional, Design, & Test Spec Development

FAT
Losses
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
Requirements
Specification
Engineering
Design Qualification
Pre-Delivery Inspection
Performance
Minimal
0 <30%
Not done
100
60%
100
7 days
Now
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
Total Man days

(approx.)
100
30 days
Post-GAMP Project
Engineering
Requirements
Specification
Comprehensive - 2 weeks
(+ several consultations)
Design Qualification
Significant
7 days
Performance
0
75% 100
90%100
Now
Pre-Delivery Inspection
5 weeks
Installation Qualification 0
Operational Qualification
Software Review
Misc. Controls
Validation
Total Man days
(approx.)
Efficiency
(Day 1)
100 Availability
(for production)
0 1%
100
Wastage
4 days
Good
Maintainability
2 weeks
Unnecessary
Retrospective
Validation
Good
Documentation
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
75%
90%
100%
0 1%
How Do I Get Started?
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
Working Session
Break into functional groups
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
Each statement:
Uniquely referenced
Less than 250 words
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
Modes of operation
Performance and timing
Failure actions
Hardware
Software
URS Content Checklist

Safety
and security
Data
Archive
Capacity
Speed
Definition of data and valid ranges
Interfaces
Environment
URS Constraints
Schedule
Compatibility with existing networks, hardware,
etc.
Reliability requirements
Legal issues, working methods, user skill levels,
etc.
Maintenance
Ease of maintenance
Expansion capability
Expected lifetime
Long-term support
URS Lifecycle
Development e.g. project

management/QA/mandatory design
methods
Testing
Special testing under load conditions

Test data
Simulations
Delivery
Shipment directions
Documents what supplier is expected to deliver
URS Lifecycle
Tools
Training
Engineering
Operations
Maintenance
Support from vendor after:

FAT
Validation complete

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GAMP/JETT AGENDA

Introduction and GAMP Organization

GAMP Forum Developments

8 New Special Interest Groups established

New groups incorporated into GAMP

GAMP Forum Organisation

GAMP Scope: Automated

Help suppliers of automated

Validation (Master) Plan &

User Requirements Specification

New Edition: GAMP 4

Software categories developed further

Best Practice Guides

Additional Planned Guides

Additional Planned Guides

VAI Automation - Chris

JETT BASELINE EXAMPLE

JETT EQUIPMENT ACQUISITION MODEL

System Acceptance Test

Interphex 1997, 2000, & 2001

URS, FRS, HDS, SDS, FAT

Barrier Isolator & HVAC

Pure Steam Generator

Wide Range Filler

Fluid Bed Dryer

GAMP Process Control

GAMP Process Control

GAMP Process Control

Systems that control the manufacturing process,

Systems that process, transfer, or store process

GAMP Process Control

GAMP Process Control

GAMP Process Control

JETT Benefits Analysis

Qualification Protocol development & execution

Functional, Design, & Test spec development

Time Savings 6 - 8 weeks

Functional, Design, & Test Spec Development

Time savings 3-10 weeks

equivalent project cost (~$2m)

Total Man days

adopt good engineering practices

How Do I Get Started?

JETT Web Site

GAMP Web Site

Break into functional groups

Select a piece of OEM equipment (simple)

Express requirements, not design solution

Distinguish between mandatory and desirable

URS Content Checklist

URS Content Checklist

Development e.g. project

Special testing under load conditions

Support from vendor after:

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