GAMP5 Presentation

GAMP5and the Alignmentto International Guidelines

52 South First Street Suite 320San Jose, California 95113P: 408.294.5500F: 408.294.5507www.veracord.com

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

21CFR PT 11Ist D

GAMP 3

21 CFR PT 112nd D

ISO 14971

GAMP 4

21 CFR PT 11Clarification Q9

ASTM E2500

Associations1848

Fed Controls Drugs

1950 1980

HACCP ISPE

ISO 9001

GAMP & ISPEDATAPROTECTION

21 CFR Pt 820

GAMP 2

GAMP 5

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

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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Specify

Configure & Code

Report

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

Presented by:

David Park Schutzpark@veracord.com408.294.5501

Mani Mohammadmani@veracord.com408.294.5502

www.veracord.com

Mary Kay Lofurno mklofurno@syberworks.com

www.syberworks.com

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