astm e2500

ASTM E2500

http://www.leanvalidation.eu/lean-validation/astm-e2500[6/23/2013 9:17:56 PM]

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ASTM E2500

ASTM E2500-7 is a consensus guide with legal reference and global impact. The has Copyright by ASTM Int'l (all rights reserved) and can be purchased at www.astm.org.

The ASTM E2500 has a lean approach for validation and is in line with FDA’s Pharmaceutical cGMP's for the 21st century, EMEA, GAMP 5 and ICH Q8 and Q9.

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ApproachThe guide allows flexibility in changes before final acceptance of the system. The level of detail for documentation is based on risk in relation to patient safety and product quality. Beforeacceptance of the system the design and implementation is done under Good Engineering Practice (GEP) by Subject Matter Experts (SME); after acceptance GMP related changes aremanaged and approved by QA.

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Key conceptsThe following key concepts are mentioned in the guide:

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Risk-based ApproachScience-based ApproachCritical Aspects of Manufacturing SystemsQuality by DesignGood Engineering PracticeSubject Matter ExpertUse of Vendor DocumentationContinuous Process Improvement

The validation process

ProcessThe validation process is divided into the following sections

Requirements definitionSpecification and designVerificationAcceptance and release

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ASTM E2500

http://www.leanvalidation.eu/lean-validation/astm-e2500[6/23/2013 9:17:56 PM]

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The supporting processesThe supporting processes support the validation during the whole process.

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risk managementdesign reviewchange management

DifferencesThe differences betwee the ASTM guide and the ISPE Baseline guide are shown in the table below.

ISPE Baseline guide ASTM guide

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Design inputsImpact assessmentDesign QualificationCommissioningMultiple trial runs to get things rightIQ, OQ, PQ and acceptance criteriaGEP Scope and QA ScopeoverlappedFocused on DocumentationDeliverablesRigid Change Management

Design inputsDesign ReviewRisk MitigationCritical Control Parameters define Acceptance CriteriaVerification TestingPerformance TestingGEP Scope and QA Scope have clear boundaryProcess, Product Quality and Patient SafetyQuality by Design, Design Space and ContinuousImprovement

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