SOPs for Biosimilars V 2.0

To establish a structured approach for performing risk assessment in the event of upstream processing failures during biosimilar manufacturing, ensuring timely identification of root causes, impact analysis, and implementation of corrective and preventive actions (CAPA).
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To outline the procedure for detecting, documenting, investigating, and responding to temperature excursions during fermentation processes in biosimilar manufacturing, ensuring product quality and regulatory compliance.
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To define the procedure for effective shift handover between outgoing and incoming personnel in biosimilar manufacturing areas to ensure accurate communication, task continuity, and compliance with GMP practices.
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To define a standard procedure for ensuring complete traceability of all materials used in upstream processes during biosimilar manufacturing, from raw material receipt to final usage, in compliance with GMP guidelines.
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To establish a validated procedure for cleaning chromatography columns used in biosimilar purification prior to reuse, in order to remove residual product, prevent cross-contamination, and maintain resin performance as per GMP and manufacturer’s guidelines.
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To define the procedure for the preparation, filtration, labeling, storage, and documentation of buffers used during harvest operations in biosimilar downstream processing to ensure product quality and GMP compliance.
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To define the strategy and procedure for planning, preparing, and maintaining back-up seed trains in biosimilar upstream processes to mitigate risk of primary seed train failure and ensure batch continuity.
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To define the validation strategy and procedure for ensuring cleaning effectiveness of single-use systems (SUS) in biosimilar manufacturing operations and to confirm the absence of cross-contamination risks, extractables, and leachables post-rinsing and usage.
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To establish a standardized gowning procedure for personnel accessing upstream manufacturing areas to minimize contamination risks and maintain aseptic and controlled conditions as per GMP guidelines.
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To define the standardized process for integrating biosensors into upstream bioreactors and conducting routine verification and calibration to ensure accurate, real-time process monitoring in biosimilar manufacturing operations.
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