Tag: GMP SOP for biosimilars

Biosimilars: SOP for Biosensor Integration and Verification – V 2.0

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Biosimilars: SOP for Biosensor Integration and Verification – V 2.0 Standard Operating Procedure for Biosensor Integration and Verification in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/140/2025 Supersedes SOP/BS/140/2022 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 standardized process for integrating biosensors into upstream…

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Biosimilars V 2.0

Biosimilars: SOP for Gowning Procedure for Upstream Suite – V 2.0

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Biosimilars: SOP for Gowning Procedure for Upstream Suite – V 2.0 Standard Operating Procedure for Gowning Procedure for Upstream Suite in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/139/2025 Supersedes SOP/BS/139/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized gowning procedure for personnel…

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Biosimilars V 2.0

Biosimilars: SOP for Cleaning Validation of Single-Use Systems – V 2.0

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Biosimilars: SOP for Cleaning Validation of Single-Use Systems – V 2.0 Standard Operating Procedure for Cleaning Validation of Single-Use Systems in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/138/2025 Supersedes SOP/BS/138/2022 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 validation strategy and procedure for…

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Biosimilars V 2.0

Biosimilars: SOP for Back-Up Seed Train Planning – V 2.0

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Biosimilars: SOP for Back-Up Seed Train Planning – V 2.0 Standard Operating Procedure for Back-Up Seed Train Planning in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/137/2025 Supersedes SOP/BS/137/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the strategy and procedure for planning, preparing, and…

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Biosimilars V 2.0

Biosimilars: SOP for Buffer Preparation for Harvest Operations – V 2.0

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Biosimilars: SOP for Buffer Preparation for Harvest Operations – V 2.0 Standard Operating Procedure for Buffer Preparation for Harvest Operations in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/136/2025 Supersedes SOP/BS/136/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for the preparation, filtration,…

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Biosimilars V 2.0

Biosimilars: SOP for Chromatography Column Cleaning Before Reuse – V 2.0

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Biosimilars: SOP for Chromatography Column Cleaning Before Reuse – V 2.0 Standard Operating Procedure for Chromatography Column Cleaning Before Reuse in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/135/2025 Supersedes SOP/BS/135/2022 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 validated procedure for cleaning chromatography…

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Biosimilars V 2.0

Biosimilars: SOP for Material Traceability in Upstream – V 2.0

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Biosimilars: SOP for Material Traceability in Upstream – V 2.0 Standard Operating Procedure for Material Traceability in Upstream Operations in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/134/2025 Supersedes SOP/BS/134/2022 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 standard procedure for ensuring complete traceability…

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Biosimilars V 2.0

Biosimilars: SOP for Shift Handover Procedures – V 2.0

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Biosimilars: SOP for Shift Handover Procedures – V 2.0 Standard Operating Procedure for Shift Handover Procedures in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/133/2025 Supersedes SOP/BS/133/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for effective shift handover between outgoing and incoming…

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Biosimilars V 2.0

Biosimilars: SOP for Temperature Excursions During Fermentation – V 2.0

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Biosimilars: SOP for Temperature Excursions During Fermentation – V 2.0 Standard Operating Procedure for Handling Temperature Excursions During Fermentation in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/132/2025 Supersedes SOP/BS/132/2022 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 procedure for detecting, documenting, investigating, and…

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Biosimilars V 2.0

Biosimilars: SOP for Risk Assessment in Upstream Failures – V 2.0

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Biosimilars: SOP for Risk Assessment in Upstream Failures – V 2.0 Standard Operating Procedure for Risk Assessment in Upstream Failure Events in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/131/2025 Supersedes SOP/BS/131/2022 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 structured approach for performing…

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Biosimilars V 2.0