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

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
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