JETT Interphex California 2000 Presentation

1
(No Transcript)
2
What is GAMP JETT?

• Good Automated Manufacturing Practice
• ISPE Industry Guidance on Computer System
  Qualification (Validation)
• Joint Equipment Transition Team
• Special Interest Group of GAMP
• Selected GAMP as common ground.
• Meet Monthly for review and development.

3
USER Representatives Abbott Labs Tim
Schuetter Pharmacia - Dale Noteboom Eli Lilly -
Bret Fisk Aventis Behring John Dexter Aventis
Pasteur Jeff ODonel Perrigo Paul Coury
CONSULTANT Reps VAI Automation - Chris Roerig
Jacobs Engrg Brokamp, Buede PV - Mike Filary,
Marieva Rivera PAC Bruce Lauderman Fluor-Daniel
Mike Humphries BEK Engr Vince Miller Brock
Solutions John, Casey
SUPPLIER Representatives Fisher-Rosemount
Jonathan Lustri Bosch /TL
Systems - Terry Petro Vector Corp - Don
Rosendale Rockwell McCarthy, Jiang BOC Edwards
Mike Stella Millipore Ramon LeDoux Invensys
Russell Regan
4
What is JETT?

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

5
The Beginning

• Started by Lilly, Pharmacia and Rockwell, June
  1996.
• Today, 16 active and 28 associate members
• Common challenges discussed
• Reduced internal resources available
• Increased purchases of packaged equipment
• Common frustration with OEM supplied
  documentation
• Increasing regulatory requirements

6
Validation and Qualification

• Design Validation - Did I make the right product
  and can I prove it?
• Process Validation - Does the process
  consistently produce a result or product meeting
  predetermined specifications and can I prove it?
• Qualification - Action of proving and documenting
  that equipment or ancillary systems are properly
  installed, work correctly, and actually lead to
  the expected results. Qualification is part of
  validation, but the individual qualification
  steps alone do not constitute process validation.
• (Source FDAs Current Good Manufacturing
  Practice)

7
GAMP Qualification Plan
A Basic Framework for Specification, Design and
Testing
GAMP 4.0 Figure 6.2
8
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

9
JETT Efforts

• Applying GAMP to Automated Equipment
• Communicating GAMP Approach
• Interphex 1997, 2000, 2001, 2002, 2003
• ISPE - Regional National Meetings
• Pharmaceutical Online Articles
• Pharmaceutical Engineering Articles
• Institute of Validation Technology Conferences
  and Articles
• Published in VPCS Supplement to GAMP 4

10
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

11
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

12
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
13
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
14
Why Do All This?

• Good Business Practice
• Aligns equipment with application
• Delivers equipment in Control, Capable,
  Consistently performing as designed
• Maintainable
• Mandatory by regulatory agencies
• FDA Food Drug Administration
• MCA Medicines Control Agency

15
How Do I Get Started?

• JETT Web Site - www.jettconsortium.com
• Meeting Dates, Places and times
• Meeting Minutes
• JETT Work Products
• Contact JETT Members for Assistance
• Contact information available on website
• Start with Baseline Piece of Equipment
• Try out JETTs URS Template approach on a project
  requiring a
• piece of equipment where JETT has a completed
  template.
• Promote with Users, QA, Suppliers
• Integrate in your Standards and Methods
• Discuss harmonization of company procedures w/
  GAMP with internal validation people