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

ISPE/GAMP
JETT
APV

Namur Group

Supplier Forum

GAMP Americas
GAMP Europe
Executive Summary of
Good Automated
Manufacturing Practice
(GAMP) Guide
 GAMP Scope: Automated
Consist of: Systems
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 PERFORMANCE

SPECIFICATION Verifies QUALIFICATION

FUNCTIONAL OPERATIONAL
SPECIFICATION Verifies QUALIFICATION

DESIGN INSTALLATION
SPECIFICATION Verifies QUALIFICATION

SYSTEM
BUILD

GAMP 4.0 Figure 6.2

Part 1: User Responsibilities
Validation (Master) Plan & System
Specific Validation Plan(s)
Appendix 6
Supplier Audit
Appendix 7
User Requirements Specification
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 Stand-
alone 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.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 ODonel
Perrigo Paul Coury
SUPPLIER Representatives
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
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
 JETT EQUIPMENT ACQUISITION MODEL
USER/(CONSULTANT if applicable) SUPPLIER
Master Validation Plan User Audit

Equipment Validation Plan Engineering Feasibility Study

Explanation to Supplier and Results

User Requirements Proposal

Specification Quality & Validation Plan Project Plan
(Living Document)

Functional Specification
Proposal Analysis (traceable to URS)

Approval Detailed Design

Review Functional Specification Documentation
(traceable to Functional Specification)

Review Detailed System Acceptance Test

Design Specifications (IQ/OQ)
Hardware Software
Review System
Acceptance Test Specifications System Acceptance
Testing and Results
User Witness Optional
Integrate with Validation
Documentation as appropriate 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 Barrier Isolator & HVAC
Autoclave 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 Tangential Flow
Filtration System
Variable Data Fluid Bed Dryer
Inspection SCADA System
Freeze Dryer
BioReactors Cappers
Tablet Coater
Building Management Blender
Purified Water
Systems
System 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 suppliers
development processes and documentation
 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

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

Engineering Performance
Requirements
Minimal 0 <30% 100
Specification Efficiency
(Day 1)
Design Qualification Not done 0 60% 100
0 7 days Now
Pre-Delivery Inspection
0 70% 100
Availability
Installation Qualification 0 5 weeks (for production)
0 8-12% 100
Operational Qualification Wastage

Software Review Not done Poor Maintainability

Misc. Controls Not done Retrospective

Significant
Validation Validation
0 100 Adequate
Total Man days Documentation
(approx.) 30 days
 Post-GAMP Project

Engineering Performance
Requirements Comprehensive - 2 weeks
Specification (+ several consultations) 0 75% 100 Efficiency
(Day 1)
Significant
Design Qualification 0 90%100
0 7 days
Now
Pre-Delivery Inspection
0 100 Availability
Installation Qualification 0 5 weeks (for production)

Operational Qualification 0 1% 100

Wastage

Software Review Maintainability

4 days Good

Misc. Controls Retrospective

2 weeks Unnecessary
Validation Validation

0 100 Good Documentation

Total Man days
(approx.) 90 days
 Summary

To derive benefit when validating

automated systems :-
post GAMP
0 75%

adopt good engineering practices 0 90%

adopt the common approach (GAMP) 0 100%
manage the benefits through
measure them 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