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GAMP5and the Alignmentto International Guidelines
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FDA’s GMP InitiativeLester M Crawford, FDA Deputy Commissioner,21st August 2002
Integration of quality systems and risk management approaches.
Enhancement of the integration of pre-approval review and cGMP programs.
Use existing and emerging science and analysis.
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Tracing the History
1997 1998 2000 2001 2003 2004 2006 2007 2008
21CFR PT 11Final Rule
Q10
Q8
21CFR PT 11Ist D
GAMP 3
21 CFR PT 112nd D
ISO 14971
GAMP 4
21 CFR PT 11Clarification Q9
1987
ASTM E2500
Associations1848
Fed Controls Drugs
1949
G2I
1946
ISO
1950 1980
HACCP ISPE
ISO 9001
1990
ICH
1991
GAMP
1991
GAMP & ISPEDATAPROTECTION
1996
21 CFR Pt 820
GAMP 2
GAMP 5
PQLI
Tracing the History
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After over 4 years of re-work GAMP 5 was released in Feb 2008, and is a major rewrite of GAMP 4 with significant changes having as primary goals:bringing procedures in line with the
dynamic Life Science industry andreducing the cost of compliance.
GAMP 5 BackgroundGAMP 5 Background
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The need to develop a Guidance that will satisfy the regulatory requirements for CSV
Scaleable approach to GxP Compliance through the complete life cycle
Drive towards Risk Based Approach
Effective Supplier Relationships
Use of Existing Documentation and Knowledge
Continuous Improvement within QMS
Quality by Design
Effective Governance to Achieve and Maintain GxP Compliance
GAMP 5 DriversGAMP 5 Drivers
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History, Alignment, ApplicationGAMP 5 leverages risk management from GAMP 4 and addresses the entire lifecycle of automated systemsGAMP 5 aligns with major industry developments including PQLI1, ICH Q8, Q9, Q10, and ASTM E2500 and points to the future of computer systems complianceGAMP 5 is applicable to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures
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ASTM E2500Based on sound scientific, engineering and quality principlesIntended to separate business risk from patient safety riskVerification is “a systematic approach to prove that critical elements acting singly or in combination are fit for intended use, have been properly installed, and are operating correctly.”The standard indicates the approach must be documented, to an extent based on risk.
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Semantics
Myth 1 – “It’s not validation it’s verification”
Concentrate not on the semantics but on what is to be accomplished
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Focus on Risk!
Myth 2 – “ISO14971 is Medical Device and I am Pharma”
So what? A risk is a risk and the methodology and principles remain the same!
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A Note on Risk ManagementSystematic process for identifying, assessing, mitigating, controlling, and communicating risk, based on • Good science• Process and product understanding
Zero risk is impractical and unattainable• Aim is for acceptable risk
Aligns with GAMP and ISO 14971Aligns with ICH Q9GAMP 5 also aligns to ASTM E2500
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GAMP – The Core Purpose
The GAMP guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practices in an efficient and effective manner.
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Practical Guidance
Facilitates the interpretation of regulatory requirements.Establishes common language and terminology.Promotes a system life cycle approach based on good practice.Clarifies roles and responsibilities.
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Drivers - Automation
Procedures & Records
Clinical TrialsPharmacovigilence
ManufacturingDistribution
InventoryManagementWarehousing
Sales & ServiceRecalls &
Complaints
Processes & Products Patients & Consumers
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Other Drivers
FDA 21st Century Risk & Science Based GMP Initiative.ICH Q9 – Quality Risk ManagementISPE Product Quality Lifecycle (PQLI) Initiative.ASTM Standards – E2500 Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems & Equipment.
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Other Drivers
FDA 21st Century Risk & Science Based GMP Initiative.ICH Q9 – Quality Risk ManagementISPE Product Quality Lifecycle (PQLI) Initiative.ASTM Standards – E2500 Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems & Equipment.
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ICH Q9 – Osaka 03 – Chicago 05
Principles of Risk ManagementResponsibilitiesInitiating a QRM processRisk AssessmentRisk FactorsTools
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Other Drivers
FDA 21st Century Risk & Science Based GMP Initiative.ICH Q9 – Quality Risk ManagementISPE Product Quality Lifecycle (PQLI) Initiative.ASTM Standards – E2500 Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems & Equipment
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ISPE - PQLI
The ISPE “Product Quality Lifecycle”Initiative for the implementation of Q8, Q9 & Q10.‘Quality by Design’ – QbD“Quality should be built into a product as
opposed to being tested for after manufacture”
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ASTM – E2500
High Cost of Qualification• Due to lack of understanding of the ‘spirit’ of
cGMPs.• Was the equipment installed properly?• Do they operate properly?• Do they meet the requirements?• Do they control risk to product quality?• Will they support process validation?
‘FIT FOR INTENDED USE’
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E2500 – Breaking the Chains
Force by Terminology?The Role of Quality• Ensure critical aspects and associated
acceptance criteria have been identified.• SME’s on the application Quality principles.• Final Determination
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Many Drivers
GAMP 5
Focus on Patient Safety,Product Quality and Data
Integrity
Lifecycle approachwithin QMS
Science Based QRM
Scaleable Approach toDxP Compliance
Effective SupplierRelationships
Use of Existing Knowledge &Documentation
ConfigurableSystems &
Development Models
Improving GxPCompliance Efficiency
Critical QualityAttributes (CQA)
ContinuousImprovement within
QMS
Quality by Design (QbD)
Effective Governance to Achieve &Maintain GxP Compliance
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KEY CONCEPTS
Lifecycle Approach within QMS
Scalable Lifecycle Activities
Process and Product Understanding
Science Based Quality Risk Management
Leveraging Supplier Involvement
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Real Examples of BenefitsThe number, scope & naming convention for project deliverables are standardized.The variability in size of key specification documents has been reduced in magnitude.Number of project roles reduced by as much as 50%Reduction in the number of approvers by as much as 54%Procedures are easier to use ( better written, simplified, use of standard templates)Average time to review documents reduced by as much as 34%Number of document versions needed before finalization down by as much as 45%Validation is easier to audit and inspectValidation costs now down to 2-5% of project.
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Plan
Specify
Configure & Code
Report
Ris
k M
anag
emen
t
Verify
The GAMP “V” Model
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ReportVerifyBuildSpecifyPlan
E2500 Process & GAMP 5
ProductKnowledge
ProcessKnowledge
RegulatoryRequirements
QualityRequirements
Requirements Specification& Design Verification Acceptance &
Release Maintain State
GOOD ENGINEERING PRACTICE
RISK MANAGEMENT
DESIGN REVIEW
CHANGE MANAGEMENT
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Ten Principles1. Focus on what affects
product quality.2. Requirements are key to
acceptability.3. Risk assessments to
identify critical features.4. Focus on critical features
for formal qualification5. All activities must
contribute value.
6. Different systems & equipment require different levels of attention.
7. Documents must serve a useful purpose.
8. Leverage Supplier documentation.
9. Test planning10.Foster Innovation
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Global Trends
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Industrial Trends
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SummaryGAMP 5 is evolutionary, not revolutionary. It aligns with ASTM E2500 and the global regulatory movement to push the Risk Management process throughout the lifecycle. When established within a business GAMP 5 provides cost effective measures for implementing systems within the Life Science industry.
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52 South First Street Suite 320San Jose, California 95113P: 408.294.5500F: 408.294.5507www.veracord.com
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Presented by:
David Park [email protected]
Mani [email protected]
www.veracord.com
Mary Kay Lofurno [email protected]
www.syberworks.com
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