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EU24CEMAR1/SES303 - Operator Aseptic Qualification for Manual Processes


‐ Mar 12, 2024 12:15pm

ATMP production is often highly manual and varied aseptic operations can occur over multiple shifts and days.  Assuring operators are adequately qualified poses a unique challenge since processes can involve multiple different types of interventions which require different aseptic skills.  In addition, the new Annex 1 requires for stringent qualification of operators in these processes.  This presentation will cover one approach for a robust operator aseptic qualification approach that balances the changing requlatory expectations, sterility assurance requirements, and business needs.  From assessing the process interventions to leveraging production data, a holistic approach is needed in the current aseptic processing environment.