Tag: cell line development SOP biosimilars

Biosimilars: SOP for Periodic Equipment Cleaning Schedule – V 2.0 Standard Operating Procedure for Periodic Equipment Cleaning Schedule in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/120/2025 Supersedes SOP/BS/120/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define a standardized approach for scheduling and executing periodic…

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Biosimilars: SOP for Training Bioreactor Operators – V 2.0 Standard Operating Procedure for Training Bioreactor Operators in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/119/2025 Supersedes SOP/BS/119/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a structured and standardized training procedure for bioreactor operators involved…

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Biosimilars: SOP for Emergency Shutdown of Bioreactor – V 2.0 Standard Operating Procedure for Emergency Shutdown of Bioreactor in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/118/2025 Supersedes SOP/BS/118/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To provide a standardized procedure for safely shutting down a…

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Biosimilars: SOP for Equipment Logbook Maintenance – V 2.0 Standard Operating Procedure for Equipment Logbook Maintenance in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/117/2025 Supersedes SOP/BS/117/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a uniform procedure for the maintenance of equipment logbooks…

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Biosimilars: SOP for Tracking Consumables in Bioreactor Runs – V 2.0 Standard Operating Procedure for Tracking Consumables in Bioreactor Runs in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/116/2025 Supersedes SOP/BS/116/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for documenting, labeling, and…

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Biosimilars: SOP for Biosafety Monitoring in Upstream Labs – V 2.0 Standard Operating Procedure for Biosafety Monitoring in Biosimilar Upstream Laboratories Department Biosimilars SOP No. SOP/BS/115/2025 Supersedes SOP/BS/115/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for biosafety monitoring in upstream…

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Biosimilars: SOP for Disposal of Culture Waste – V 2.0 Standard Operating Procedure for Disposal of Culture Waste in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/114/2025 Supersedes SOP/BS/114/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for biosafety-compliant collection, inactivation, segregation, and…

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Biosimilars: SOP for Inactivation of Used Culture Broth – V 2.0 Standard Operating Procedure for Inactivation of Used Culture Broth in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/113/2025 Supersedes SOP/BS/113/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for safe, compliant, and…

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Biosimilars: SOP for Microbial Excursions Handling – V 2.0 Standard Operating Procedure for Microbial Excursions Handling in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/112/2025 Supersedes SOP/BS/112/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a systematic approach for the detection, investigation, response, and…

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Biosimilars: SOP for Media Compatibility Assessment – V 2.0 Standard Operating Procedure for Media Compatibility Assessment in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/111/2025 Supersedes SOP/BS/111/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for evaluating the compatibility of cell culture…

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