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AABB Accreditation

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Satisfying Validation and Calibration Requirements for AABB Accreditation
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  Biometrix Corporation 800-890-8909www.biometrix.com 1 Satisfying Validation andCalibration Requirementsfor AABB Accreditation  Biometrix Corporation 800-890-8909www.biometrix.com 2 Validation and Calibration for AABBAccreditation  AABB Accreditation now requires full cGMP calibration andvalidation compliance “Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP)regulations, CLIA ’88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality Management systems, competition within the blood banking profession, advances inthe cellular therapy arena, and increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy communitiesconduct business. Conducting business in a quality framework is no longer an option,but a must. Ensuring that all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.”  -AABB website  Biometrix Corporation 800-890-8909www.biometrix.com 3 Validation and Calibration for AABBAccreditation  AABB requires that all accredited facilitiesvalidate their processes:AABB Standard: 5.0 Process ControlThe facility shall identify, design, and validate the policies, processes andprocedures that affect the quality of cellular therapy products and services.  Biometrix Corporation 800-890-8909www.biometrix.com 4  Specific cGMP requirements  Calibration plan  Calibration files for each instrument, withinstrument information forms and calibrationcertificates  NIST-traceable Calibration of critical equipment  Validation plan  Validation of critical equipment Validation and Calibration for AABBAccreditation

Conceito Maitland

Aug 22, 2017
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