ASTM E2500

A New Approach to Validation

Peter K. Watler, Ph.D.,
Principal Consultant and CTO,
Hyde Engineering + Consulting, Inc.
-Page 1-
Where you can find it
Only 5 pages
http://www.astm.org/Standards/E2500.htm
$36.00
-Page 2-
ASTM E 2500 07, What is it?
A risk-based and science-based approach to the specification,
design, and verification of manufacturing systems and equipment that
have the potential to affect product quality and patient safety.
The overall objective is to provide manufacturing capability to support
defined and controlled processes that can consistently produce
product meeting defined quality requirements.
Approved June 1, 2007
A voluntary consensus standard
It has legal relevance
Stresses expert analysis of critical element that affect product quality
quality, (not Quality Assurance or Quality Unit) appears 44 times
expert appears 21 times
critical appears 20 times
-Page 3-
The National Technology Transfer Act of 1995
Public Law 104-113
The Congress finds the following:
(1) Bringing technology and industrial innovation to themarketplace
is central to the economic, environmental, and social well-being of
the people of the United States.
(2) The Federal Government can help United States business
to speed the development of new products and processes
Provision (12(d)) - Utilization of Consensus Technical
Standards by Federal Agencies;
all Federal agencies and departments shall use technical
standards that are developed or adopted by voluntary consensus
standards bodies, using such technical standards as a means to
carry out policy objectives or activities deemed by the agencies and
departments.
-Page 4-
What the Law Looks Like
http://www.nist.gov/director/ocla/Public_Laws/PL104-113.pdf
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What ASTM E 2500 Applies To
Pharmaceutical and biopharmaceutical
manufacturing systems:
Facility equipment
Process equipment
Supporting utilities
Process monitoring systems
Process control systems
Automation
Systems that have the potential to affect
product quality
patient safety
-Page 6-
ASTM E 2500-07 Highlights
The ASTM standard focuses on
Specification
Design
Verification
Lifecycle
Alternative to ISPE Baseline Guide Vol 5 Commissioning &
Qualification
complexity, cost, time
Replaces Design Qualification with a Design Review by Subject Matter
Experts
Risk Assessments by Subject Matter Experts (SMEs)
Eliminate Impact Assessment
Replaces sequential Commissioning and Qualification with Verification
Fit for intended use - Not bound by the formal IQ, OQ PQ phases
Lifecycle Change
Continuous process improvements and real-time monitoring (PAT)
-Page 7-
Why is it needed now?
It is estimated that validation
can add up to 25% of the
total installation cost for new
facilities.
M Guyader, LBP
E 2500 puts focus on
Critical areas that affect
Product Quality
Patient Safety
I know Nothing!
Lets Validate
Everything!
-Page 8-
Whats Driving us to Consider new Validation
Approaches
Pharmaceutical manufacturing operations are
inefficient and costly.
Pharmaceutical manufacturing will need to
employ innovation, cutting edge scientific &
engineering knowledge.
"if we change the way both manufacturers and
regulators operate, the industry could save an
average of 15 per cent of manufacturing costs".
Source: PAT Team & Manufacturing Science Working Group Report , 2004

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If FDA could change the way it
regulated
the industry could save
10 to 50% of the cost of goods sold.
Pharmaceutical Manufacturing Research Project Benchmarking Study, Georgetown University, October 2006
-Page 9-
They Have!
FDA 2004: Pharmaceutical cGMPs for the 21st Century A Risk
Based Approach
Encourage implementation of risk-based approaches
FDA 2004: PAT A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance
encourage the voluntary development and implementation of
Process Analytical Technology
FDA 2006: A Regulatory Paradigm to Encourage Innovation. Keith
Webber, CDER/OPS, FDA
FDA 2006: Guidance for Industry Q9 Quality Risk Management
FDA 2007: Pharmaceutical Quality for the 21st Century A Risk-
Based Approach Progress Report
FDA 2009: Guidance for Industry Q8(R1) Pharmaceutical
Development
science- and risk-based submissions QbD
-Page 10-
3
Focus on Criticality, Ongoing Verification
-Page 11-
Why Now?
Industry and Regulatory Agencies are striving to
be more efficient, reduce costs and improve
quality and safety
Decades of pharma & bio manufacturing
experience
More knowledge of systems
Solid understanding of operations
Less anything can happen philosophy
-Page 12-
Implementing ASTM E 2500
Some will wrongly interpret this as simply shifting validation
responsibilities:
This new approach will significantly shift the current qualification
responsibilities and activities associated with facility qualification,
equipment qualification, and utility qualification to the companys
corporate engineering group
Some will wrongly interpret this as simply changing the
terminology:
Out goes the Design Qualification (DQ) with a Design Review (DR).
Also for those that do them, Impact Assessments are out. Commissioning and
Qualification are replaced by Verification,
the qualification phases (IQ, OQ, PQ) are obsolete.
ASTM E 2500 is a new Concept, requiring new Approaches
Its more than simply re-naming documents
Its more than a re-org of shifting responsibilities from one group
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Implementing ASTM E 2500
To implement the concepts of E 2500
Approach has to change
Expertise (of the people involved) has to change
Tools have to change
Otherwise there will be no real change
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Is ASTM E 2500 About This?
OLD
NEW?
-Page 15-
GAMP Validation V Model
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ASTM E 2500 Is:
A standard approach for validating equipment,
facilities, processes
Streamlined process
Risk based reduce costs
QbD develop then employ best practices
More consistent qualification
Supports current regulatory guidance (FDA, ICH)
Knowledge (expert) based
Risk based
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ASTM E 2500 Process Map
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Planning
& Documentation
Identify
Subject Matter
Experts
User
Requirements
Specification
Risk
Assessment
Functional
Specifications
and Design
Verification Plan
Factory
Acceptance
Tests
Site
Acceptance
Tests
Installation/
Operational
Qualification
Tests
Performance
Qualification
Tests
Verification Summary Report
GMP Operation and
Change Management
Vendor
Documentation
ETOP
E2500 System Lifecycle and Validation Approach
Traceability
Matrix
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The New Standard is About Fundamental Change!
RiskBased Approach
Science Based Approach
Quality by Design (QbD)
Process Analytical
Technologies (PAT)
Design Space
Critical Parameters
Critical Quality Attributes (CQA)
Knowledge & Understanding
Subject Matter Experts (SMEs)
Good Engineering Practice,
(GEP)
Lifecycle concepts
Change implementation
Continuous process
improvement
Vendor documentation
To more efficiently and better, design and implement
manufacturing systems
ASTM E 2500 embraces, leverages and brings together the
cutting edge concepts of:
-Page 20-
E 2500 Key Concepts for Design &
Implementation of Manufacturing Systems
Methodologies
1. Requirements
2. Specification & Design
3. Verification
Toolbox
1. Design Review
2. Subject Matter Experts
3. Risk Management
Process
4. Change Management
Plan
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Benefits of Implementing E 2500
LEANer manufacturing systems
Remove waste
Elevate our industry to more knowledge, better
understanding of our manufacturing systems
Data, PAT, Design Space
Focus on whats important (Critical)
More is not better
Better technical understanding (Subject Matter Experts)
Less waste & repetition
Use vendor docs
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Implementing ASTM E 2500
1. Planning and Documentation:
VMP
Verification Team and Responsibilities
Document Matrix (planning, design & verification)
Eligible vendor documentation
Document Matrix prepared by: Date: 20-Oct-09
HYDE
Task
Title Doc. # Status Doc. # Status Doc. # Status Doc. # Status FAT SAT IOQ PQ Enhanced
Comm
IOQ PQ Summary
Reports
002
FMECA RISK
ASSESSMENT SOP
TEC-005 APPROVED
19MAY09
002
COMMISSIONING PLAN COM-001 APPROVED
24JUL09
002
VERIFICATION PLAN
PROTOCOL TEMPLATE
APPROVED
04AUG09
003
HVAC SYSTEM- AIR
HANDLERS
URS-50058-
66
APPROVED
29SEP09
RSK-50058-
66
DRAFT
004
AUTOCLAVE (2 DOOR) URS-50043 APPROVED
13MAY09
RSK-50043 APPROVED
25JUN09
005
BAS- BUILDING
AUTOMATION SYSTEM
URS-50054 APPROVED
08AUG09
RSK-50054 DRAFT
006
CHILLER SYSTEM URS-50050 APPROVED
02JUL09
007
CLEAN DRY AIR SYSTEM URS-50049 APPROVED
25JUN09
RSK-50049 APPROVED
18SEP09
008
COOLING TOWER
SYSTEM
URS-50056 APPROVED
09JUL09
009
ELECTRICAL/ LIGHTING
SYSTEM
010
EMERGENCY
GENERATORS
URS-50053 APPROVED
03AUG09
RSK-50053 APPROVED
03AUG09
Phase 2 Design & Development Phase 1 Planning and Definition Validation
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Implementing ASTM E 2500
2. Identify Subject Matter Experts:
(6.7) SMEs have primary responsibility for specification, design and
verification of the manufacturing systems
individuals with specific expertise and responsibility in a particular
area or field (for example, quality unit, engineering, automation,
development, operations.
CFR21 211.34 Consultants advising on the manufacture,
processing, packing, or holding of drug products shall have sufficient
education, training, and experience, or any combination thereof, to
advise on the subject for which they are retained.
Who are they?
Where do you find them?
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SME Qualifications
Experience
>10 y experience
Designed & implemented systems or practices
Process/System Expertise
Knowledge of GMP, compliance, design elements, risk factors
Applies engineering equations, principles to the design, sizing & scaling
of systems.
In-depth knowledge of the subject
Methodology Expertise
Proficient in standard methodologies for design and implementation,
such as ICH Quality Guidelines (Q8, Q9, Q10), FDA Guidance, CFRs,
ASME Standards (BPE, E 2500), ISPE Guides (GAMP, Baseline)
Completed formal training courses
Recognized Competence
Recognized by peers and professional associations, published, teaches
topic
Professional credentials, license
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Implementing ASTM E 2500
3. Requirements Specification:
Identify specific requirements
Basis for specification, design,
and verification of the system (7.2)
SMEs
product and process knowledge
and understanding
based on scientific data (QbD,
Design Space).
This knowledge is the basis of scientific understanding for the system
FDA 2009: Guidance for Industry Q8(R1) Pharmaceutical Development
What is critical
SME
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Implementing ASTM E 2500
4. Risk Management Process
FDA 2006: Guidance for Industry [ICH] Q9
Quality Risk Management
Perform risk assessments at appropriate stages to
evaluate the risks to product quality and patient safety
Performed by an appropriate SME
Identify controls and verification techniques to
manage risk to an acceptable level
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Implementing ASTM E 2500
5. Specification and Design :
Leverage qualified equipment vendor expertise (SME)
to identify & document elements which affect critical quality
attributes
Communicate the factors that impact product quality to the
system (e.g. equipment) designer.
Strive to mitigate product quality & patient safety risks
through the design
Functional Specifications provide acceptance criteria for
functional tests specified in the Verification Plan.
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Potential Design Requirements
Temperature
Shear
Flow rate
Membrane Area
Requirements Definition:
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Implementing ASTM E 2500
6. Verification Plan (5.1, 7.4)
Verify the critical aspects of the manufacturing system
Design
Properly installed
Operating correctly
Meets performance requirements
Fit for intended use
Identifies all required testing & documentation
Extent of verification and documentation should be based on risk to
product quality and patient safety
Criticality, risk factors identified in the URS, FMECA Risk Analysis, and
detailed design
Testing occurs from FAT to PQ
Acceptance criteria:
Developed and approved by subject matter experts
Critical aspects approved by the quality unit
A Traceability Matrix summarizes required testing and when it occurs
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Verification Plan Traceability Matrix
Identifies required test
functions
Identifies when testing
will be executed
FAT, SAT, IQ, OQ, PQ
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Implementing ASTM E 2500
7. Verification Plan Execution:
Subject matter experts perform or oversee activities, and
document results (7.4.3.1)
Vendor verification documentation may be used (7.4.3.2)
Leverage FAT/SAT testing rather than repeating vendor
activities and replicating vendor documentation (6.8.2)
Testing occurs across FAT, SAT, IQ, OQ, PQ
The more critical testing or additional testing may occur during IQ/OQ
to mitigate risk
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The Role of System Vendors
The key to a competitive parts supply system is the way the
assembler works with its suppliers Womack, The Story of Lean Production
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Implementing ASTM E 2500
8. Verification Summary Report
Approved FAT, SAT, ETOP, IOQ and PQ Reports collectively provide
documented verification that the manufacturing system is fit for
intended use (E 2500 7.5.1)
Summary Report provides an overview of test results and non-
conformances with acceptance criteria (7.5.2)
Completed verification documentation reviewed by qualified and
independent subject matter expert(s) (7.4.4.1)
SME reviews overview of results and any nonconformance with
critical acceptance criteria
Systems with critical aspects should be approved by the quality unit.
SME confirms manufacturing system is fit for intended us (7.5.3)
Approved by SME and Quality Assurance (7.5.4).
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Implementing ASTM E 2500
9. GMP Operation Acceptance, Release & Change
Management:
After Verification Summary Report approval,
Quality Assurance issues authorization to release the system for GMP
operational use (7.5.5).
As part of the system life-cycle, equipment, and procedures are
periodically reviewed.
Modifications are controlled via Change Management throughout the
system lifecycle (E 2500 8.4.3).
Changes are approved by system subject matter experts.
Changes to critical aspects or to aspects that affect system requirements
relative to product quality and patient safety are additionally approved by
Quality Assurance (8.4.2, 8.4.3)
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The Role of QA in ASTM E 2500
7.4.1.3 Acceptance criteria of critical aspects (that is, critical to product
quality and patient safety) should be approved by the quality unit.
7.4.2.3 The verification plan should be developed and approved by
subject matter experts. Verification plans for systems containing critical
aspects should be approved by the quality unit.
7.5.4 Such documentation should be prepared and approved by
subject matter experts. Such documentation for systems with critical
aspects should be approved by the quality unit.
8.4.2 Before acceptance, change management should be applied. This
process should be managed by, and changes approved by, subject
matter experts. Changes affecting critical aspects of manufacturing
systems should be communicated to the quality unit.
8.4.3 After acceptance, prior to manufacturing for commercial use,
operational change management should be applied. Under operational
change management, all changes related to specific requirements
relative to product quality and patient safety require prior approval by
the quality unit, unless predefined arrangements are established
covering
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What Else is Needed?
Risk Management Process
ICH Q9
Perform risk assessments at appropriate stages to
evaluate the risks to product quality and patient safety
Performed by an appropriate SME
Identify controls and verification techniques to
manage risk to an acceptable level
-Page 37-
Although there are some examples of the use of quality
risk management in the pharmaceutical industry today,
they are limited and do not represent the full contributions
that risk management has to offer.
Risk Based Quality Systems
Risk Based Validation
Risk Based Process Monitoring
Risk Based Documentation
ICH Published 09 Nov 2005
FDA Published Federal
Register, June 2, 2006
Risk Management Program
-Page 38-
ICH Q9 Describes Several Risk Assessment Tools
Basic Risk Management Facilitation Methods
(Flowcharts, Check Sheets Etc.)
Failure Mode Effects Analysis (FMEA)
Failure Mode, Effects and Criticality Analysis (FMECA)
Fault Tree Analysis (FTA)
Hazard Analysis And Critical Control Points (HACCP)
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
Risk Ranking and Filtering
Supporting Statistical Tools
-Page 39-
Risk Management - FMEA Method
Severity
addresses the impact on a process in the event a parameter is
out of range.
Occurrence
assesses the likelihood a parameter will be out of range.
Detection
addresses the ability of detecting a defect if a parameter is out
of range.
Risk Priority Number
RPN = Severity x Occurrence x Detection
-Page 40-
FMEA Risk Assessment - Identifying Criticality
Assemble multidisciplinary team
Manufacturing, Process Development, Manufacturing Sciences,
Engineering and Quality Assurance
Prepare FMEA Data Sheet
All operating inputs and proposed operating ranges
What are the potential failure modes (process, equipment,
operators)
Typical sources of failure in systems
What are causes of these failures
Scoring based upon
Knowledge, known equipment capability, maintenance
Previous experience and expertise
-Page 41-
Risk Assessment SOP
-Page 42-
FMEA Worksheet
Severity x Occurrence x Detection = RPN
Process
Unit Operation
Leader
Participants
Operational Parameter Current Range Failure Mode Cause(s) Potential Effect(s) Severity Occurrence Detection RPN
Preparation
Verify TFF-08207 is within cleaning
expiration date
30 days Out of date Operator error / Process delay
Expired equipment used in
process
Install dip tubes Incorrect dip tube orientation
Operator error / Incorrect
alignment of alignment pin
Foaming / Over concentration /
Yield loss
Perform pre-use visual inspection Clean Not cleaned Faulty cleaning cycle
Dirty equipment used in
process
Set-up TFF for processing per MO173 System set-up incorrectly
Operator error / Incorrect SOP
revision
Production delay / Product loss
System hose connections
Incorrect system hose
connections
Operator error
Inadequate flushing of system /
Product loss
Connect chilled water supply
Incorrect connection / utilities
failure
Utilities failure / Operator error
Temperature spike / Product
loss
Conncect AWFI
Incorrect connection / utilities
failure
Utilities failure / Operator error
Inadequate flushing of system /
Product loss
Conncect CDA
Incorrect connection / utilities
failure
Utilities failure / Operator error
System will not operate / valves
will not toggle
Drain the system per MO173 System not drained Operator error / Equipment failure
System not flushed of storage
solution
Verify Hydraulic Pressure Unit is in the run
setting
> 1150 psig
Incorrect pressure on
membranes
Wrong setting selected / Faulty
Hydraulic Pressure Unit
Membranes not sealed /
Product loss
Open and download file "Automated TFF
Method VER01"
Wrong file downloaded Operator error Product Loss
Buffer Manifold Flush
Flush valves for > 2
min
Valves not flushed for
sufficient tim
Incorrect flow rate / Valve failure
System not flushed of storage
solution
System AWFI flush
System not adequately
flushed with AWFI
Incorrect system connections /
Insufficient volume / Incorrect flow
path
System not flushed of storage
solution / Product loss
Robert S, Bill E, Fred J, Mary S, Jill R
Failure Modes and Effects Analysis
Healgen
TFF
John Smith
-Page 43-
System or Process Name: Compiled by:
Reference Drawings
URS
Component Description
& Function
Potential Failure Mode Potential Failure Effects Potential Failure Causes Compensating Provisions
S
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Recommended
Actions
Resp. Actions Taken
S
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Revised Conditions
Team:
Original Date: Revision Date:
System/Process
Failure Mode, Effects and Criticality Analysis
(FMECA)
System Owner: Primary SME:
Existing Conditions
FMEA Worksheet
Severity x Occurrence x Detection = RPN
-Page 44-
FMECA Worksheet
Component Descri pti on
& Funct ion
Pot ent ial Failure Mode Potential Fai l ure Effects Potenti al Fai l ure Causes Compensati ng Provisions
S
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3 WFI Distribution System WFI distribution pipe
Contamination
WFI water quality out of spec Dead leg, Non-turbulent flow,
wrong surface finishing and/or
incompatible material (MOC) for
WFI piping
Check design, commissioning,
validation, PM & EM program
8 5 5 200
Particle Test
Program
-Yearly
by
Intarcia?
Commissioning & Qualification Testing (RPN=200
Undesirable)
1. Verify no dead leg L/D >2.0
2. Verify surface finish
3. Verify MOC (elastomers, SS grade)
4. Verify Reynolds number (circulation
flowrate)
5. Verify Design Review
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Actions
Taken
Res
p
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Recommended Actions
-Page 45-
Criticality Ranking
1 2 4 6 8 10
Certain Very High Moderate Low Remote Uncertain
100 100 200 400 600 800 1000
80 80 160 320 480 640 800
70 70 140 280 420 560 700
60 60 120 240 360 480 600
50 50 100 200 300 400 500
42 42 84 168 252 336 420
36 36 72 144 216 288 360
30 30 60 120 180 240 300
24 24 48 96 144 192 240
16 16 32 64 96 128 160
12 12 24 48 72 96 120
9 9 18 36 54 72 90
6 6 12 24 36 48 60
1 1 2 4 6 8 10
Number of
RPN's in Range
Intolerable 343-1000 37
Undesirable 189-336 26
Tolerable 72-180 23
Negligible 1-70 34
Commission
ACTION
Moderate Risk
Detection Rank
Design modification required to mitigate risk
Qualification testing or design modification required to mitigate risk
Qualification testing may be required to mitigate risk
Risk Score
High Risk
Low Risk
RISK CRITICALITY
-Page 46-
Manufacturing FMEA
RPNs can range from 1 to 1,000
RPN 100 indication may be a high risk item
Manufacturing:
Nine unit operations analyzed
FMEA evaluated 445 operational inputs
RPNs ranged from 3 to 158
Only 6 operational inputs received RPN scores 100
Indicates robustness, procedural controls and equipment
capabilities have minimized the risk of failure
Fewer parameters to validate
More Targeted Validation
Better understanding, better quality, lower cost
-Page 47-
FMEA Results
Validate only CRITICAL & KEY Parameters
From FMEA
From Severity
From Knowledgebase
Unit Operation Parameter RPN
Production Fermentation
Raw Material Addition 111
Production Fermentation
Sampling for Culture Purity Analysis 102
SEC
Elution Buffer (BT018) pH 158
SEC
Elution Buffer (BT018) Conductivity 155
SEC
Load Volume 144
SEC
Remove Bioburden, LAL Samples 113
-Page 48-
FMECA Risk Analysis Report

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-Page 49-
E 2500 Implementation Gaps
ASTM E 2500 lays out a standard roadmap for the overall
approach
It is not a how to guide,
Firms should develop appropriate mechanisms to communicate
requirement inputs, including product quality considerations, to
those responsible for design
Firms will need to develop
Processes
Tools & templates suited to their operations
Not one size fits all needs to address corporate risk,
nature of business, expertise of staff, organization
resources
-Page 50-
What Else is Needed?
Design Review Process
Planned and systematic reviews throughout the system lifecycle:
Specifications
Design
Design development
Continuous improvement changes
Ensure product and process requirements are satisfied by
the design
Unacceptable risks are mitigated by design or other means
Design is performed by appropriate SMEs
-Page 51-
What Else is Needed?
Change Management Process
Develop a change management plan before releasing the system
Change is good, is expected
Managed by, changes approved by SMEs
Changes affecting critical aspects communicated to the quality unit
Changes related to product quality and patient safety
require prior approval by the quality unit, unless predefined
plan
PAT provides scientific data to support changes and
manage risk
-Page 52-
ASTM E 2500 The Role of Vendors
The key to a competitive parts supply system is the way
the assembler works with its suppliers
(Womack et al., 1990)
Partner with a supplier (LEAN)
vs
Bid them against each other (MASS)
Preferred Suppliers
Few in number, single sourced?
Share information needs, specifications
Supplier becomes the solution provider
Encourages use good vendor documentation and testing
to support qualification
-Page 53-
Implementation Gaps
Gaps
How do you do a risk assessment eg. FMEA SOP?
How often, at what points in the process?
How do you qualify to be an SME?
How many QA staff will be needed? What expertise will they need?
Where will you find them?
How do you manage changes during design & implementation?
How do you manage change to enable improvements to be
implemented?
How do you efficiently address deviations from the Verification
Plan?
How do you determine the Critical aspects of the manufacturing
system
How to define & document the verification approach
-Page 54-
E 2500 Implementation Gaps
ASTM E 2500 lays out a standard roadmap for the overall
approach
It is not a how to guide,
Firms should develop appropriate mechanisms to communicate
requirement inputs, including product quality considerations, to
those responsible for design
Firms will need to develop
Processes
Tools & templates suited to their operations
Not one size fits all needs to address corporate risk,
nature of business, expertise of staff, organization
resources
-Page 55-
E 2500 Efficiency & Cost Savings
The extent of verification and the level of detail of
documentation should be based on risk, including
those associated with product quality and patient
safety, and the complexity.
Only companies that achieve a high level of
process understanding will have the opportunity
to justify a more flexible regulatory path.
FDA 2004
-Page 56-
Yes, ASTM E 2500 is Being Implemented
Hyde Client, Commercial Device Facility
E2500 Based facility and systems commissioning and qualification
Amgen, Thousand Oaks Clinical Mfg
50-70% reduction in IQ/OQ for chromatography skid
Phil Bowles, ISPE Tampa 2009
Bristol-Myers Squibb Biologics
Applying ASTM E2500 to a Greenfield Site
E Bramhall, Director Validation, ISPE 2008 Annual Meeting
Perkin Elmer
Best Practices for Qualification of Laboratory Equipment
Utilizing ASTM E2500
Major East Bay Pharmaceutical Company
Risk based commissioning & qualification
Major Bay Area Biotech Company
Risk based validation for new facility commissioning
-Page 57-
FDA Guidance
Guidance for Industry Process Validation:
General Principles and Practices - FDA Nov 18
2008 Guidance
In keeping with the spirit of ASTM E 2500
Standard, the document uses the term verify
rather than validate when referring to facility
systems.
IQ, OQ, DQ, PQ are industry terms and standards,
not FDA mandated.
-Page 58-
Summary
ASTM E 2500-07 provides a cutting edge
framework for planning and execution of riskbased
approach to designing and implementing reliable
manufacturing systems
ASTM E 2500 has many parallels to existing
approaches, but relies on more risk management
and higher expertise
The challenge is to address the implementation
gaps and develop the custom tools
-Page 59-
Contact Info
Peter K Watler, PhD
Principal Consultant and
Chief Technology Officer
Hyde Engineering + Consulting, Inc.
peter.watler@hyde-ec.com
415-235-1911