GAMPJETT AGENDA

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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

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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)

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GAMP Forum Organisation
APV
Namur Group
Supplier Forum
GAMP Americas
GAMP Europe
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Executive Summary of Good Automated Manufacturing
Practice (GAMP) Guide
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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

• 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.

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GAMP Qualification Plan
A Basic Framework for Specification, Design and
Testing
USER REQUIREMENT
PERFORMANCE

Verifies
SPECIFICATION
QUALIFICATION

FUNCTIONAL
OPERATIONAL
SPECIFICATION
QUALIFICATION

Verifies

DESIGN
INSTALLATION
SPECIFICATION
QUALIFICATION
Verifies

SYSTEM
BUILD
GAMP 4.0 Figure 6.2
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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

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New Edition GAMP 4
Strategic Framework
Quality Management Procedures
Practical Guidance (Good Practice)
Training/Materials Workshop
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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.

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Best Practice Guides

• First Wave
• Calibration
• IT Infrastructure Networks, Desktop,
• Harmonized Terminology
• Electronic Records and Signatures

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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

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Additional Planned Guides

• Third Wave
• Legacy Systems
• Clinical Systems
• Medical Devices
• E-Applications Web-based software
• Manufacturing Execution Systems

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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.JETTconsortiu
m.com)
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Mission Statement

• Improve communications between Users and
  Suppliers to more effectively meet the
  validation requirements of the pharmaceutical
  industry.

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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
• BEK Engr Vince Miller
• Brock Solutions John, Casey
• 14 Active Members
• 45 Assoc. Members Growing

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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)

Master Validation Plan
User Audit
Equipment Validation Plan
Engineering Feasibility Study and
Results
P.O.

• Explanation to Supplier

RFQ
User Requirements Specification (Living Document)
Proposal

• Project Plan

• Quality Validation Plan

Proposal
P.O.
Proposal Analysis
Approval
Detailed Design Documentation (traceable to
Functional Specification)
Review Functional Specification
Approval
System Acceptance Test Specifications (IQ/OQ)
Review Detailed Design

• Hardware

• Software

Review System Acceptance Test Specifications
Approval
System Acceptance Testing and Results User
Witness Optional

Integrate with Validation Documentation as
appropriate

Maintenance Support Documentation

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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

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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

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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

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JETT Efforts

• Released URS Documents

Vial Washer Barrier Isolator HVAC
System Chromatography Pure Steam Generator
Glassware Washers Saturated Steam
Autoclave Label Rewinder Labeler Multiple-Effect
Still
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JETT Efforts

• URS Documents in development

Granulators Tablet Press Variable Data
Inspection BioReactors Building Management Systems
Centrifuge CIP Systems Fluid Bed Dryer Freeze
Dryer Tablet Coater Purified Water System
Wide Range Filler Tangential Flow Filtration
System SCADA System Cappers Blender Depyrogenation
Tunnel
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GAMP Process Control Supplement

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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.

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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

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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

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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

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GAMP Process Control Supplement - Release

• Global Introduction of the VPCS Guide
• ISPE Washington Continuing Advancement Conference
  June 4 Arlington, VA

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JETT Benefits AnalysisChris Roerig
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Benefits of JETT Approach

• Provides Standards/Guidelines for
• Project Lifecycle
• Deliverables
• Documentation
• Approvals
• Industry Consistency

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Benefits of JETT Approach

• "Speed to Market"
• Smoother Procurement Process
• Smoother Validation Process
• Shorter Project Schedule
• Reduced Project Costs
• Integration Services
• Validation
• Re-work

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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

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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

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Savings Analysis of Purchase Price

• Consultant 3 - 4 savings
• Gains
• Functional, Design, Test Spec Development
• FAT
• Losses
• Integrator Audits
• Time savings 3-10 weeks

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Real World Example
Courtesy of Dr. David Selby, David Begg
Associates, Kirkbymoorside, N. Yorks, UK YO6 6AX
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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)

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Pre-GAMP Project
Engineering
Performance
Requirements Specification
Minimal
Efficiency (Day 1)
Not done
Design Qualification Pre-Delivery
Inspection Installation Qualification Operationa
l Qualification Software Review
0
7 days
Now Availability (for production) Wastage Maint
ainability Retrospective Validation
5 weeks
0
Not done
Poor
Misc. Controls Validation Total Man
days (approx.)
Not done
Significant
Documentation
0 100
Adequate
30 days
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Post-GAMP Project
Engineering
Performance
Comprehensive - 2 weeks ( several consultations)
Requirements Specification
Efficiency (Day 1)
Significant
Design Qualification Pre-Delivery
Inspection Installation Qualification Operationa
l Qualification Software Review
0
7 days
Now Availability (for production) Wastage Maint
ainability Retrospective Validation
4 days
Good
Misc. Controls Validation Total Man
days (approx.)
Unnecessary
Documentation
2 weeks
0 100
Good
90 days
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Summary
To derive benefit when validating automated
systems -
post GAMP
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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

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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

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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

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URS Content Checklist

• Functions required
• Product requirement
• Functional requirement
• Design requirement
• Modes of operation
• Performance and timing
• Failure actions
• Hardware
• Software

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URS Content Checklist

• Safety and security
• Data
• Archive
• Capacity
• Speed
• Definition of data and valid ranges
• Interfaces
• Environment

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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

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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

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URS Lifecycle

• Tools
• Training
• Engineering
• Operations
• Maintenance
• Support from vendor after
• FAT
• Validation complete