Astm e2500

ASTM E2500

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ASTM E2500

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. Add new comment

Approach The 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. Before acceptance of the system the design and implementation is done under Good Engineering Practice (GEP) by Subject Matter Experts (SME); after acceptance GMP related changes are managed and approved by QA. Add new comment

Key concepts The following key concepts are mentioned in the guide: Risk-based Approach Science-based Approach Critical Aspects of Manufacturing Systems Quality by Design Good Engineering Practice Subject Matter Expert Use of Vendor Documentation Continuous Process Improvement

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The validation process

Process The validation process is divided into the following sections Requirements definition Specification and design Verification Acceptance and release

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

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ASTM E2500

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The supporting processes The supporting processes support the validation during the whole process. risk management design review change management

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Differences The differences betwee the ASTM guide and the ISPE Baseline guide are shown in the table below. ISPE Baseline guide Design inputs Impact assessment Design Qualification Commissioning Multiple trial runs to get things right IQ, OQ, PQ and acceptance criteria GEP Scope and QA Scope overlapped Focused on Documentation Deliverables Rigid Change Management

ASTM guide Design inputs Design Review Risk Mitigation Critical Control Parameters define Acceptance Criteria Verification Testing Performance Testing GEP Scope and QA Scope have clear boundary Process, Product Quality and Patient Safety Quality by Design, Design Space and Continuous Improvement

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