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ASTM E2500A New Approach to Validation
Peter K. Watler, Ph.D., Principal Consultant and CTO,
Hyde Engineering + Consulting, Inc.
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Where you can find it
Only 5 pageshttp://www.astm.org/Standards/E2500.htm$36.00
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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, 2007A voluntary consensus standardIt 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 themarketplaceis central to the economic, environmental, and social well-being of the people of the United States. (2) The Federal Government can help United States businessto 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
-Page 5-
What ASTM E 2500 Applies To
Pharmaceutical and biopharmaceutical manufacturing systems:
Facility equipmentProcess equipmentSupporting utilitiesProcess monitoring systemsProcess control systemsAutomation
Systems that have the potential to affect product qualitypatient safety
-Page 6-
ASTM E 2500-07 Highlights
The ASTM standard focuses onSpecificationDesignVerificationLifecycle
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 ChangeContinuous 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!
Let’s Validate Everything!
-Page 8-
What’s 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“Pharmaceutical Industry Wastes
$50 Billion a Year Due to Inefficient
Manufacturing”
Pharmaceutical Manufacturing Research Project , Georgetown University, October 2006
“If FDA could change the way it regulated…
the industry could save10 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
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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
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Implementing ASTM E 2500
Some will wrongly interpret this as simply shifting validation responsibilities:
“This new approach will significantly shift the current qualificationresponsibilities and activities associated with facility qualification, equipment qualification, and utility qualification to the company’s 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 ApproachesIt’s more than simply re-naming documentsIt’s 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 changeExpertise (of the people involved) has to changeTools have to change
Otherwise there will be no real change
-Page 14-
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 processRisk based – reduce costsQbD – develop then employ best practicesMore consistent qualificationSupports 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
UserRequirementsSpecification
Risk Assessment
FunctionalSpecificationsand Design
Verification Plan
FactoryAcceptance
Tests
SiteAcceptance
Tests
Installation/OperationalQualification
Tests
PerformanceQualification
Tests
Verification Summary Report
GMP Operation andChange Management
VendorDocumentation
ETOP
E2500 System Lifecycle and Validation Approach
TraceabilityMatrix
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The New Standard is About Fundamental Change!
RiskBased ApproachScience Based ApproachQuality by Design (QbD)Process AnalyticalTechnologies (PAT)Design SpaceCritical ParametersCritical Quality Attributes (CQA)
Knowledge & UnderstandingSubject Matter Experts (SMEs)Good Engineering Practice, (GEP)Lifecycle conceptsChange implementationContinuous process improvementVendor documentation
To more efficiently and better, design and implement manufacturing systems…
ASTM E 2500 embraces, leverages and brings together the cutting edge concepts of:
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E 2500 Key Concepts for Design &Implementation of Manufacturing Systems
Methodologies
1. Requirements2. Specification & Design3. Verification
Toolbox
1. Design Review2. Subject Matter Experts3. Risk Management
Process4. Change Management
Plan
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Benefits of Implementing E 2500
LEANer manufacturing systemsRemove waste
Elevate our industry to more knowledge, better understanding of our manufacturing systems
Data, PAT, Design Space
Focus on what’s important (Critical)More is not better
Better technical understanding (Subject Matter Experts)
Less waste & repetition Use vendor doc’s
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Implementing ASTM E 2500
1. Planning and Documentation:VMPVerification Team and ResponsibilitiesDocument 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
002FMECA RISK ASSESSMENT SOP
TEC-005 APPROVED 19MAY09
002COMMISSIONING PLAN COM-001 APPROVED
24JUL09
002VERIFICATION PLAN PROTOCOL TEMPLATE
APPROVED 04AUG09
003
HVAC SYSTEM- AIR HANDLERS
URS-50058-66
APPROVED 29SEP09
RSK-50058-66
DRAFT
004AUTOCLAVE (2 DOOR) URS-50043 APPROVED
13MAY09RSK-50043 APPROVED
25JUN09
005BAS- BUILDING AUTOMATION SYSTEM
URS-50054 APPROVED 08AUG09
RSK-50054 DRAFT
006
CHILLER SYSTEM URS-50050 APPROVED 02JUL09
007CLEAN DRY AIR SYSTEM URS-50049 APPROVED
25JUN09RSK-50049 APPROVED
18SEP09
008
COOLING TOWER SYSTEM
URS-50056 APPROVED 09JUL09
009ELECTRICAL/ LIGHTING SYSTEM
010
EMERGENCY GENERATORS
URS-50053 APPROVED 03AUG09
RSK-50053 APPROVED 03AUG09
Phase 2 Design & DevelopmentPhase 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 experienceDesigned & implemented systems or practices
Process/System ExpertiseKnowledge of GMP, compliance, design elements, risk factorsApplies 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 topicProfessional credentials, license
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Implementing ASTM E 2500
3. Requirements Specification:Identify specific requirementsBasis for specification, design,and verification of the system (§7.2)
SMEs product and process knowledge and understandingbased 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 ProcessFDA 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
TemperatureShearFlow rateMembrane 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
DesignProperly installedOperating correctlyMeets performance requirements“Fit for intended use”
Identifies all required testing & documentationExtent of verification and documentation should be based on risk to product quality and patient safetyCriticality, risk factors identified in the URS, FMECA Risk Analysis, and detailed designTesting occurs from “FAT” to “PQ”
Acceptance criteria:Developed and approved by subject matter expertsCritical 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 functionsIdentifies 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, PQThe 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 theassembler works with its suppliers” – Womack, The Story of Lean Production
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Implementing ASTM E 2500
8. Verification Summary ReportApproved FAT, SAT, ETOP, IOQ and PQ Reports collectively providedocumented verification that the manufacturing system is fit forintended 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 establishedcovering
Mitigate Risk with Additional Oversight
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What Else is Needed?
Risk Management ProcessICH Q9Perform 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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“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 SystemsRisk Based ValidationRisk Based Process MonitoringRisk Based Documentation
ICH Published 09 Nov 2005FDA Published Federal Register, June 2, 2006
Risk Management Program
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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 FilteringSupporting Statistical Tools
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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 NumberRPN = Severity x Occurrence x Detection
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FMEA Risk Assessment - Identifying Criticality
Assemble multidisciplinary teamManufacturing, Process Development, Manufacturing Sciences, Engineering and Quality Assurance
Prepare “FMEA Data Sheet”All operating inputs and proposed operating rangesWhat are the potential failure modes (process, equipment, operators)Typical sources of failure in systemsWhat are causes of these failures
Scoring based uponKnowledge, known equipment capability, maintenancePrevious experience and expertise
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Risk Assessment SOP
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FMEA WorksheetSeverity 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
PreparationVerify 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
membranesWrong setting selected / Faulty
Hydraulic Pressure UnitMembranes not sealed /
Product lossOpen 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 AnalysisHealgen
TFF
John Smith
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System or Process Name: Compiled by:
Reference Drawings
URS
Component Description & Function Potential Failure Mode Potential Failure Effects Potential Failure Causes Compensating Provisions
SEV
OCC
DET
RPN
Recommended Actions Resp. Actions Taken
SEV
OCC
DET
RPN
Revised Conditions
Team:
Original Date: Revision Date:
System/ProcessFailure Mode, Effects and Criticality Analysis
(FMECA)
System Owner: Primary SME:
Existing Conditions
FMEA WorksheetSeverity x Occurrence x Detection = RPN
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FMECA Worksheet
Component Description & Function Potential Failure Mode Potential Failure Effects Potential Failure Causes Compensating Provisions
SEV
OCC
DET
RPN
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 >2.02. Verify surface finish3. Verify MOC (elastomers, SS grade)4. Verify Reynolds number (circulation flowrate)5. Verify Design Review
RPN
DET
OCC
SEV
Actions Taken
Resp.
Recommended Actions
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Criticality Ranking
1 2 4 6 8 10Certain Very High Moderate Low Remote Uncertain
100 100 200 400 600 800 100080 80 160 320 480 640 80070 70 140 280 420 560 70060 60 120 240 360 480 60050 50 100 200 300 400 50042 42 84 168 252 336 42036 36 72 144 216 288 36030 30 60 120 180 240 30024 24 48 96 144 192 24016 16 32 64 96 128 16012 12 24 48 72 96 1209 9 18 36 54 72 906 6 12 24 36 48 601 1 2 4 6 8 10
Number of RPN's in Range
Intolerable 343-1000 37Undesirable 189-336 26Tolerable 72-180 23Negligible 1-70 34 Commission
ACTION
Moderate Risk
Detection Rank
Design modification required to mitigate riskQualification testing or design modification required to mitigate riskQualification testing may be required to mitigate risk
Risk Score
High Risk
Low Risk
RISK CRITICALITY
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Manufacturing FMEA
RPN’s can range from 1 to 1,000RPN ≥100 indication may be a high risk item
Manufacturing:Nine unit operations analyzedFMEA evaluated 445 operational inputsRPN’s 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 failureFewer parameters to validateMore Targeted ValidationBetter understanding, better quality, lower cost
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FMEA Results
Validate only CRITICAL & KEY ParametersFrom FMEAFrom SeverityFrom 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
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FMECA Risk Analysis Report
“conducted in accordance with… good documentation
practices.
This recommendation is consistent with ICH guidance
for industry, Q10 Pharmaceutical Quality System.9 241
Decisions and justification of the controls should be
sufficiently documented” – FDA Guidance Nov 18, 2008
-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, tothose responsible for design”
Firms will need to developProcessesTools & 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 ProcessPlanned 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 ProcessDevelop a change management plan before releasing the systemChange is good, is expectedManaged by, changes approved by SMEsChanges 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
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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, specificationsSupplier becomes the solution provider
Encourages use good vendor documentation and testing to support qualification
-Page 53-
Implementation Gaps
GapsHow 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, tothose responsible for design”
Firms will need to developProcessesTools & 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 FacilityE2500 Based facility and systems commissioning and qualification
Amgen, Thousand Oaks Clinical Mfg50-70% 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 EquipmentUtilizing ASTM E2500”
Major East Bay Pharmaceutical CompanyRisk based commissioning & qualification
Major Bay Area Biotech CompanyRisk 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 riskbasedapproach 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, PhDPrincipal Consultant andChief Technology Officer
Hyde Engineering + Consulting, Inc.