Tag: purification skid calibration SOP

Biosimilars: SOP for Sampling During Night Shifts – V 2.0 Standard Operating Procedure for Sampling During Night Shifts in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/110/2025 Supersedes SOP/BS/110/2022 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 aseptic, accurate, and timely…

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Biosimilars: SOP for Tank-to-Tank Transfer of Cultures – V 2.0 Standard Operating Procedure for Tank-to-Tank Transfer of Cultures in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/109/2025 Supersedes SOP/BS/109/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for aseptic and controlled transfer of…

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Biosimilars: SOP for Aseptic Handling During Inoculation – V 2.0 Standard Operating Procedure for Aseptic Handling During Inoculation in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/108/2025 Supersedes SOP/BS/108/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the aseptic techniques and procedural steps required during…

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Biosimilars: SOP for Seed Train Validation – V 2.0 Standard Operating Procedure for Seed Train Validation in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/107/2025 Supersedes SOP/BS/107/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for validation of the seed train process used…

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Biosimilars: SOP for Carbon Dioxide Sparging – V 2.0 Standard Operating Procedure for Carbon Dioxide Sparging in Biosimilar Bioreactor Operations Department Biosimilars SOP No. SOP/BS/106/2025 Supersedes SOP/BS/106/2022 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 carbon dioxide (CO₂) sparging in bioreactor…

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Biosimilars: SOP for Oxygen Enrichment Protocols – V 2.0 Standard Operating Procedure for Oxygen Enrichment Protocols in Biosimilar Bioreactor Operations Department Biosimilars SOP No. SOP/BS/105/2025 Supersedes SOP/BS/105/2022 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 protocol for controlled oxygen enrichment in bioreactor systems…

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Biosimilars: SOP for Raw Data Archival and Review – V 2.0 Standard Operating Procedure for Raw Data Archival and Review in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/104/2025 Supersedes SOP/BS/104/2022 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 procedure for the collection,…

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Biosimilars: SOP for Electronic Batch Record (EBR) Entry – V 2.0 Standard Operating Procedure for Electronic Batch Record (EBR) Entry in Biosimilar Upstream Manufacturing Department Biosimilars SOP No. SOP/BS/103/2025 Supersedes SOP/BS/103/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for accurate, timely,…

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Biosimilars: SOP for Deviation Management During Upstream Runs – V 2.0 Standard Operating Procedure for Deviation Management During Upstream Runs in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/102/2025 Supersedes SOP/BS/102/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for identifying, documenting, evaluating,…

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Biosimilars: SOP for Monitoring and Logging of Critical Parameters – V 2.0 Standard Operating Procedure for Monitoring and Logging of Critical Parameters in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/101/2025 Supersedes SOP/BS/101/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for real-time…

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