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GAMP Overview Presentation 04-03-2012 FINAL
GAMP Overview Presentation 04-03-2012 FINAL
Agenda
20 Years of the GAMP Organization
GAMP Benefits
GAMP Contribution
Validation Productivity
Lean Validation
plus
April 10, 2012
Steering Committee
Chairman:
Kevin Martin, Azzur Group
Co-Chairman:
Michael Rutherford, Eli Lilly
Secretary:
Lorrie Schuessler, GSK
ISPE Staff PM
Scott Ludlum
GAMP Europe
Laboratory Systems
Supplier Relationships
Outsourcing and Offshoring (with USA)
Calibration
GAMP Italia
Metrics
GAMP Nordic
Virtualization
2.
3.
4.
5.
6.
7.
8.
9.
GAMP 5
GAMP 5 Overview
Published: Feb 2008
Global Standards
10
Report
Validation
Activities
Blended specifications (e.g.
URS/FS,
FS/DS, even URS/FS/DS)
Design review as opposed to formal DQ
Blending
User of classical qualification
Acceptance of
Verifies(e.g. IOQ, OQ/PQ, melding
Requirements
testing
computer
validation
with
equipment
C&Q)
(URS)
(PQ)
Plan
Functional
Specification
(FS)
Development
Activities
Design
Specify
Specification
Risk
Management
throughout the
Verifies
process
(DS)
Report
Functional
testing
(OQ)
Verifies
Installation
Verify
Verification
Activities
(IQ)
11
migration
Model
URS
Release
Changes
GxP Assessment
Concept
Project
Operation
Retirement
Supplier
Involvement*
12
Plan
Specify
Build
Verify
Report
Risk mgmt
throughout
process
Good science
13
14
Desired State
High
Medium
Low
High
Medium
Low
15
Performing as expected
from the beginning
continuously
with minimal attention
16
17
Universal Approach
GAMP methodology applies to all
types of systems
Large database systems
Process control systems
Spreadsheets etc.
Needs tailoring to each project for
maximum efficiency
18
Uniform Approach
The V model is almost universally
applicable
It is capable of considerable flexibility
Many dialects exist
Fundamentals remain
Document
Handover
Design Review
Protocols
Change management
ISPE CASA Technology Show
19
Planning
Specifications
Risk-based approach
Verification
Documentation
Change management
Continuous improvement
20
Knowledge of Systems
To validate effectively we need to know our
systems;
21
Policies and
Procedures
Good Project
Management Practices
Validation Planning
Validation Strategy
Specifications and
Design Review
Protocols
Documentation
Change Management
Practices
Training
Handover
Maintaining Control in
Operation
Post-project reviews
22
Benchmark Assessment
Highest scores highlighted Green
Next lowest highlighted Yellow
Lowest Scores highlighted Red
Absolute numbers not meaningful
Averages are more reliable
Look at the concentration of colour
23
10
Protocols,
6
8
6
Documentation
6
8
8
Change
8
7
8
Management
10
6
Training
Policies and
4
Procedures7
3
7
7
8
4
6
Specifications
and
5
6
5
Design
Review
9
Project
2
4
Management
5
4
Planning
5
7
Strategy
7
4
Handover
4
4
3
Control in Operation
3
6
5
Post-project Reviews
145
137
133
126
120
154
165
162
121
97
101
79
6.6
6.2
6.0
5.7
5.5
7.0
7.5
7.4
5.5
4.4
4.6
3.6
Post-GAMP2
Specification
Development
5 days
Specification
Development
5 weeks
Protocol Development
1 week
Protocol Development
4 weeks
FAT Testing
3 days
FAT Testing
2 weeks
Initial efficiency
35%
Initial efficiency
75%
Final Efficiency
65%
Final Efficiency
95%
25
26
Scenario:
Lead site
Decision to use validation rigor (GAMP Methodology) for
all modules
Lead by QA validation expert
Tough to get Finance to understand what that meant
IT Project manager: This guy has no idea how to
implement a finance system.
Testing went like a dream!
Project on time and on budget
Weve never had a test phase that went so smoothly with
so few problems
27
Validation Waste
Waiting
Motion
Slow project
initiation
Inactive
players
Physical
document
circulation
Sequential
activities
Priority
conflicts
Long lead
times for
meetings
High training
requirement
Defects
Late
detection
Staff
turnover
Wrong
skills mix
Effort to
re-work
WASTE
Implementation of
optional features
Unclear
purpose
Multiple
planners
Multiple
forms
Too many
signatures
Over-production
Transportation
Too many
documents
Too many
people
Inventory
Extra Processing
28
Savings identified:
Adopting good practices
~5%
~30+%
~20%
Scaled approach
~10%
Leverage supplier expertise
Rigorously applied risk-based approach
29
Upgrade Projects
Cost Savings*
50%
58%
72%
Total Savings
>$1.5m
30
Medium
Low
Definition
Criteria
Product is unusable or
ineffective such that harm is
likely.
Loss or corruption of records
has potential for severe harm to
patients.
....and so on for your
organisation.
31
1 (Customised)
2 (Configurable)
3 (Non-Configurable)
High (H)
Intensive
Standard
Minimal
Medium (M)
Intensive
Standard
Minimal
Low (L)
Standard
Minimal
Minimal
Rigor of Verification
Intensive
Standard
Minimal
High: functions impacting product release, process control, batch records, complaints, recall,
regulatory filings, adverse event recording etc.
Medium: functions impacting support processes driven by GMP regulations, critical business processes
Low: functions impacting supporting processes NOT driven by regulation
Acknowledgment: Lily Mo, Pfizer Global Quality Operations
April 10, 2012
32
System
Business Workflow Mapping Tool
Limited configuration required to
implement at customers site
Approach
Extended audit to verify Supplier
Functional Risk Assessment and Testing
Additional effort, 4 days to conduct the
review of Functional Risk Assessment
and Supplier Testing
Outcome
Regulated company testing more spot
checks of high impact functions (3 days)
Original regulated company test plan
allowed for 6 man weeks testing
Acknowledgment: Chris Reid, Integrity Solutions Ltd.
April 10, 2012
33
Pre GAMP
Requirements
unclear/incomplete
Projects over-ran
Post GAMP
Adoption of lifecycle approach
Brought discipline (painfully!)
Users understood business
processes
Users understood business
needs
Requirements and quality
attributes traceable to business
process
Requirements prioritised
Compliance to timelines and
costs (mostly)
System understood by users
Systems accepted by users
Traceability made maintenance
easy
34
35
36
Problem Statement
COST OF VALIDATION
TIME
37
No uniform practice
Unclear expectations
Unclear roles and responsibilities
Duplication of effort and rework
Significant resource commitment
Inconsistencies
Functionally siloed activities
Re-interpretation of requirements leading to
re-drafting of protocols
Multiple reviews / approvals for each protocol
April 10, 2012
38
schedule
cost
Work environment
stress
anxiety
morale
39
churn
OQ
PQ
rework
40
41
Re-design Tools
Defined, integrated work flow process
Identification of key milestones
identified interdependencies between
construction & qualification activities
Responsibilities Matrix
Defined roles and responsibilities
Standard Qualification templates
Process & Packaging Equipment
Laboratory Systems
Any Automation!!!
42
Cost Savings
Reduced cost to less than 20% of
capital expenses
Achieved a cost profile of 10% or less
of capital expenses
Eliminating or reducing non-value
added work
43
44
Document Approvers
Typical approval cycle is five
validation documents approvers
Lean Approach: Should be two
document approvers
System Owner
Quality
45
46
Verification Forms
Implementation of verification forms instead
of protocols
Driven by SOP
Individual Forms are pre-approved
Installation & Functional Verification forms
Forms can be created by leveraging existing
protocols
47
Security verification
Recipe verification
Audit trail verification
Parameter verification
P&ID verification
Loop check verification
48
49
And to promote:
50
51
6.6
6.2
6.0
5.7
5.5
7.0
7.5
7.4
5.5
4.4
52
4.6
3.6
53
High
April 10, 2012
Medium
ISPE CASA Technology Show
Low
54
on planning
using risk management
using the expertise of SMEs
on design review
55
Handover
data accessibility for users
knowledge transfer
measured performance criteria
56
57
from
58
Thank You!
Resources / More Information
Kevin C. Martin
GAMP Americas Chair
Azzur Group LLC
Sr. Vice President
+1.215.260.6327
kevin.martin@azzurgroup.com
Michael L. Rutherford
GAMP Americas Vice Chair
Consultant Business Systems Support
Development Center of Excellence
Eli Lilly and Company
317-276-1473
ml.rutherford@lilly.com
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