Amnon Eylath

A hands-on and innovative Quality leader and consultant. Contributing to the development and implementation of GXP Quality Management Systems and Operations, ensuring compliance across preclinical (GLP, etc.) and clinical studies, CMC, Clinical and Commercial Manufacturing, QA-Operations, Analytical Development & QC, Validation, and distribution activities. With a career span of over 30 years in Biologics, CGT, and Small Molecules, I have cultivated expertise in GXP audits, operational quality, third-party vendor management, and electronic document management systems.

My mission is to ensure compliance with global GxP (GLP, GMP, GCP, GVP, and GDP) regulations, guidance, standards and best practices, while preparing for and supporting health authority inspections and regulatory submissions. I strive to offer innovative, science and compliance – based solutions for Global GXP Audits, critical deviations/CAPA, complex GXP investigations & risk assessments, Data Integrity, Source Data Verification, process improvements, as well as aseptic equipment and facility challenges, contributing to delivering safe, compliant and effective BioPharma drugs and therapies. Support for regulatory communications and submissions to Health Authorities (FDA, MHRA, EMA, etc.)

Having proposed and spearheaded the development and application of Phase Appropriate GMPs, first at Eli Lilly, and then globally, by influencing FDA to partner with the PDA, industry experts and European regulators to draft and issue PDA Technical Report TR 56 “Application of Phase-Appropriate Quality Systems and GMP for the Manufacturing of Biological Drug Substance”, I have a deep understanding of the principles and practical implementation of Phase-Appropriate GMP as applies to Quality Management Systems, SOPs and in practical execution in the field.

A major re-write of TR 56 was just completed for a new, revised version planned for release in 1Q26. The latest TR 56 revision inspired the co-authors to start work on another PDA technical report – TR 56-2 to cover phase appropriate GMP for ATMP, which is now being drafted by the task force members. We hope to be able to share TR 56 with our industry and regulator peers and engage with interested colleagues early next year. Stay in tune for the updates!

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