GAMP5

GAMP as part of Your Quality System
a collaborative quality program for System Integrators
Paul Bennison
Industrial Applications Team
ISAThe Instrumentation, Systems, and Automation Society
Background
Today, our pharmaceutical customers typically procure automated

systems via relatively small local system integrator companies
These companies have widely different capabilities and interpretations of how to
comply to cGxP quality requirements
Project execution standards, both in terms of cost control and meeting schedules,
vary dramatically for one integrator to another
Large international pharmaceutical companies are looking to off load the burden of
managing many small suppliers in disparate locations
A need for a collaborative Quality System program for system

integrators exists
GAMP as Part of Your Quality System
What is Validation?
How does a Quality System Assist Validation?
Automation System procurement example showing both Equipment

Supplier and User Responsibilities
Implementation Challenges
Why is Validation of Computer Systems Important?

What is GAMP? And Why was GAMP developed?
Establishing a Culture of Procedural Change

Document Management / Change Control
Quality System Summary
Benefits of a GAMP based approach

Actual example, ROI measurement with and without GAMP
What is Validation?
The FDA has defined Validation as:
Establishing documented evidence which provides a high degree of

assurance that a specific process will consistently produce a product
meeting its pre-determined specifications and quality attributes
Key Words:
Documented evidence
Pre-determined specifications
Validation can be re-stated as a means of proving that the

requirements for a system have been:
defined in advance, and that the system has been tested to prove that these
requirements have been met and proof that each step has been completed by objective
evidence in the form of documentation
Why is validation of Computer

Systems Important?
It can be argued that it is more important to apply the principles

of validation to automated systems than to any other aspect of a
pharmaceutical process.
Automated systems, especially software components cannot be tested

in the same way as a physical product
Software is different, all software programs contain errors. How it is used will determine
whether the errors become apparent or not.
Software application complexity can mean that we could not test every permutation of
inputs and use cases
Therefore end line testing (while still an important feature of a good quality system)
cannot be relied upon on its own to ensure product quality
The FDA believes that the only way to develop validatable software is
within a Quality Regulated Environment.
What is GAMP and why was it developed?
GAMP - Good Automated Manufacturing Practice
1990, the UK Pharmaceutical Industry Computer Systems Validation

Forum (GAMP Forum) was set up to promote the better understanding
of validation of automated systems in pharmaceutical manufacturing
improve understanding of the regulations and their interpretation, to improve
communication within the pharmaceutical industry and with its suppliers
Why was GAMP developed?
Each company, and indeed each project team within a company,

tended to apply personal preferences rather that a methodology for
compliance
To provide suppliers with a universal standard that would meet the requirements of the
pharmaceutical industry
An independent standard that can be referenced within commercial contracts, Suppliers
can concentrate on quality concepts such as repeatability
GAMP Guide and Special Interest Groups
Guide releases and publication dates
GAMP Organization
V 1.0, March 1995

V 2.0 May 1996
V 3.0 March 1998
V 4.0 Dec 2001
Europe and America
10 Special Interest Groups (SIGs)
JETT and Process Control
Source: JETT Consortium
How a Quality System assists Validation
FDA believes that companies with effective Quality

Systems provide the best environment for developing
software
The repeatability and control over events that are

essential for the development of validatable systems are
best provided by a formal quality system. Systems that
regulate:
What Actions are taken on a project
How they are executed, and by Whom
What Steps are to be taken to Confirm that they have been implemented
correctly
Implementation Using GAMP Guidelines
Keys steps involved for suppliers of computer systems to

ensure that their products can be successfully validated
GAMP 4.0 Figure 6.2
Automated System procurement model

User
Supplier
User Audit
Master Validation Plan

Equipment Validation Plan
Explanation to Supplier
User Requirements
Specification
(Living Document)
Proposal Analysis
P.O.
Engineering Feasibility Study

and Results
RFQ
al
p os
o
r
P
Quality & Validation Plan Project Plan
P.O.
Functional Specification
Proposal
(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
Source: JETT Consortium
Approval
Approv
al
System Acceptance Test

Specifications (IQ/OQ)
Hardware Software
System Acceptance
Testing and Results
User Witness Optional
Maintenance & Support
Documentation
Users Activities
User Requirements Document
Vendor Audits
Prior to awarding a contract the vendors quality system and their

ability to meet the user requirements need assessment
Specification Review and Approval
Without a well defined Users requirements, all other validation

efforts are pointless
Users should review and approve the Validation Strategy, and

updates to UR, FS and test specifications
Factory Acceptance Testing
Prior to delivery of a system, the system (SW) should be tested. A

Users representative should witness this
Users Activities
Installation Qualification
Confirms the H/W, electrical system drawings are same a specified

and has been installed correctly
GAMP 4, Documented evidence that the system has been installed according to
written and pre-approved specifications
Operational Qualification
A full functional test of the system prior to its intended use

GAMP 4, Documented evidence that the system operates in accordance to written
pre-approved specifications through the specified operating ranges
Performance Qualification
Establish documented evidence that the system performs in a

repeatable and stable manner over a number of batches or a period
of time
Quality System Program - Lifecycle
Phase 1. the development of Written Procedures that control

each critical phase of the project
review draft quality program with pharmaceutical manufacturers

review draft procedures with system integrators
Release of the Quality System
Quality Policy - QP001

Issue and Control of Procedures - QP002
Issue and Control of Documents - QP003
System Configuration and Change Control - QP004
Training - QP005
Project Validation Plans - QP006
System design and Test Specifications - QPxxx etc..

Design Documentation

Test Documentation
Managing Customer Expectations and

System Design
Specification
System Test Specification
Project
Deliverables
Establishing a Culture of Procedural Control
Variation In Acceptance Standard
Documentation Management and Change Control
Establishing a Culture of Procedural Control
Many software developers are resistant to ideas of working

within the confines of specifications and procedures
developed by others
A well defined quality system should not prohibit creativity or
improvements to a product
Undocumented maverick engineering efforts play no part in
this industry
Documentation Management
Effective documentation management is, arguably, the corner

stone of compliance. If doubt is cast over the timeline of data
creation or its accuracy, then all the other efforts expended can
be rendered worthless.
Follow the document lifecycle from creation, review, approval
issue, transmittal, change, re-issue, archival, and withdrawal
The cost of implementing a formal document management
software application, that manages e-signatures, security, audit
trails is beyond the means of many System Integrators
Lack of a collaborative solutions
Variation In Acceptance Standard
Despite GAMP being available since mid 90s, there is still a

wide degree of variation within the pharmaceutical industry to
what defines the minimum acceptable standards
It is not uncommon to see projects where documents are
created with the correct titles: URS, FS etc. However, upon
close inspection it becomes clear that the documents were
produced only to create the impression of a quality approach,
and were not referenced during the development of the
system
Collaborative Engineering - Document Management and Change Control
Remote
Engineering Teams
Lead PM
Sales
Accounting &
Administration
OEM Supplier
Specialty
Engineering
System Integrators
Customer
Need to Collaborate
Project/Engineering
Infrastructure
Remote
Engineering Teams
Lead PM
Sales
Accounting &
Administration
OEM Supplier
Specialty
Engineering
System Integrators
Customer
Collaborative Engineering - Document Management and

Change Control
Change control continues to be a problem in the

pharmaceutical industry. Even where very high standards
were employed during the development of a computer
system, experience indicates that the System Development
Life Cycle (SDLC) often breaks down as soon as post
validation changes are made
SDLC: reference: GAMP 3, Volume1, Part 1, Section 7, Figure 7.3 The
Validation Concept Applied to the Development Life- Cycle of an Automated
System
GAMP Methodology ROI Analysis

Courtesy of:
Dr. David Selby,
David Begg Associates,
Kirkbymoorside,
N. Yorks, UK
YO6 6AX
Scenario
two equivalent sterile filling lines
equivalent equipment train
Ampoules (pre GAMP)

Vials (post GAMP)
Tunnel sterilizer
Filler
Automatic crack detection
Automatic particulate inspection
Equivalent project cost ($2m)
Pre GAMP
Requirements
Specification
Minimal
0 <30%
Design Qualification
Not done
Pre-Delivery Inspection
100
60%
100
7 days
Now
0
70% 100
5 weeks
Installation Qualification 0
0 8-12%
Efficiency
(Day 1)
100
Availability
(for production)
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
Requirements
Specification
Comprehensive - 2 weeks
(+ several consultations)
Design Qualification
Significant
75% 100 Efficiency

(Day 1)
90%100
Now
7 days
Pre-Delivery Inspection
5 weeks
Installation Qualification 0
Software Review
Misc. Controls
Validation
Total Man days
(approx.)
4 days
2 weeks
100
100 Availability
(for production)
0 1%
100 Wastage
Good
Maintainability
Unnecessary
Retrospective
Validation
Good
Documentation
90 days
Summary
GAMP should be the corner stone of your Quality System
FDA believes that companies with effective Quality Systems

provide the best environment for developing software
A Quality System derived from GAMP provides a consistent set of
development methods to aide and achieve validation
Collaborative Infrastructure Tools
Provides a geographically distributed project engineering team

the means through which consistent development methods
(GAMP/QMS) can be deployed
a collaborative quality program
for End Users, System Integrators
and OEMs

a quality program for System Integrators
Paul Bennison
Schneider Electric - Pharmaceutical Competency Center
Raleigh, NC 919 855 1182
PAUL.BENNISON@MODICON.COM
GAMP Information sources:
WWW.GAMP.ORG
WWW.JETTCONSORTIUM.COM

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GAMP as part of Your Quality System

a collaborative quality program for System Integrators

ISAThe Instrumentation, Systems, and Automation Society

GAMP as part of Your Quality System

Today, our pharmaceutical customers typically procure automated

A need for a collaborative Quality System program for system

ISAThe Instrumentation, Systems, and Automation Society

GAMP as Part of Your Quality System

How does a Quality System Assist Validation?

Automation System procurement example showing both Equipment

Why is Validation of Computer Systems Important?

Establishing a Culture of Procedural Change

Quality System Summary

Benefits of a GAMP based approach

ISAThe Instrumentation, Systems, and Automation Society

The FDA has defined Validation as:

Establishing documented evidence which provides a high degree of

Validation can be re-stated as a means of proving that the

ISAThe Instrumentation, Systems, and Automation Society

Why is validation of Computer

It can be argued that it is more important to apply the principles

Automated systems, especially software components cannot be tested

ISAThe Instrumentation, Systems, and Automation Society

What is GAMP and why was it developed?

GAMP - Good Automated Manufacturing Practice

1990, the UK Pharmaceutical Industry Computer Systems Validation

Why was GAMP developed?

Each company, and indeed each project team within a company,

ISAThe Instrumentation, Systems, and Automation Society

GAMP Guide and Special Interest Groups

Guide releases and publication dates

V 1.0, March 1995

Europe and America

10 Special Interest Groups (SIGs)

JETT and Process Control

Source: JETT Consortium

ISAThe Instrumentation, Systems, and Automation Society

How a Quality System assists Validation

FDA believes that companies with effective Quality

The repeatability and control over events that are

ISAThe Instrumentation, Systems, and Automation Society

Implementation Using GAMP Guidelines

Keys steps involved for suppliers of computer systems to

GAMP 4.0 Figure 6.2

ISAThe Instrumentation, Systems, and Automation Society

Automated System procurement model

Master Validation Plan

Engineering Feasibility Study

Quality & Validation Plan Project Plan

Source: JETT Consortium

System Acceptance Test

ISAThe Instrumentation, Systems, and Automation Society

User Requirements Document

Prior to awarding a contract the vendors quality system and their

Specification Review and Approval

Without a well defined Users requirements, all other validation

Users should review and approve the Validation Strategy, and

Factory Acceptance Testing