Tag: SOP for ELISA-based clone screening

Biosimilars: SOP for Equipment Maintenance Log Review – V 2.0

Posted on By

Biosimilars: SOP for Equipment Maintenance Log Review – V 2.0 Standard Operating Procedure for Equipment Maintenance Log Review in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/130/2025 Supersedes SOP/BS/130/2022 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 periodic review and verification of…

Read More “Biosimilars: SOP for Equipment Maintenance Log Review – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Batch Documentation Approval – V 2.0

Posted on By

Biosimilars: SOP for Batch Documentation Approval – V 2.0 Standard Operating Procedure for Batch Documentation Approval in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/129/2025 Supersedes SOP/BS/129/2022 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 consistent and GMP-compliant procedure for reviewing, verifying, and approving…

Read More “Biosimilars: SOP for Batch Documentation Approval – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Media Filtration Before Use – V 2.0

Posted on By

Biosimilars: SOP for Media Filtration Before Use – V 2.0 Standard Operating Procedure for Media Filtration Before Use in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/128/2025 Supersedes SOP/BS/128/2022 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 sterile filtration of culture media…

Read More “Biosimilars: SOP for Media Filtration Before Use – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Water for Injection (WFI) Systems Usage – V 2.0

Posted on By

Biosimilars: SOP for Water for Injection (WFI) Systems Usage – V 2.0 Standard Operating Procedure for Water for Injection (WFI) Systems Usage in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/127/2025 Supersedes SOP/BS/127/2022 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 procedure for the…

Read More “Biosimilars: SOP for Water for Injection (WFI) Systems Usage – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Steam-In-Place (SIP) Procedures – V 2.0

Posted on By

Biosimilars: SOP for Steam-In-Place (SIP) Procedures – V 2.0 Standard Operating Procedure for Steam-In-Place (SIP) Procedures in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/126/2025 Supersedes SOP/BS/126/2022 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 validated and standardized procedure for executing Steam-In-Place (SIP) of…

Read More “Biosimilars: SOP for Steam-In-Place (SIP) Procedures – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Chemical Preparation Area Operations – V 2.0

Posted on By

Biosimilars: SOP for Chemical Preparation Area Operations – V 2.0 Standard Operating Procedure for Chemical Preparation Area Operations in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/125/2025 Supersedes SOP/BS/125/2022 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 safe, accurate, and GMP-compliant preparation…

Read More “Biosimilars: SOP for Chemical Preparation Area Operations – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Compressed Air Quality Verification – V 2.0

Posted on By

Biosimilars: SOP for Compressed Air Quality Verification – V 2.0 Standard Operating Procedure for Verification of Compressed Air Quality in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/124/2025 Supersedes SOP/BS/124/2022 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 standardized method for verifying the quality…

Read More “Biosimilars: SOP for Compressed Air Quality Verification – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Monitoring Power Supply Stability – V 2.0

Posted on By

Biosimilars: SOP for Monitoring Power Supply Stability – V 2.0 Standard Operating Procedure for Monitoring Power Supply Stability in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/123/2025 Supersedes SOP/BS/123/2022 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 procedure for monitoring power supply stability…

Read More “Biosimilars: SOP for Monitoring Power Supply Stability – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Control System Backup and Restoration – V 2.0

Posted on By

Biosimilars: SOP for Control System Backup and Restoration – V 2.0 Standard Operating Procedure for Electronic Control System Backup and Restoration in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/122/2025 Supersedes SOP/BS/122/2022 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 systematic backup…

Read More “Biosimilars: SOP for Control System Backup and Restoration – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Validation of Upstream Processes – V 2.0

Posted on By

Biosimilars: SOP for Validation of Upstream Processes – V 2.0 Standard Operating Procedure for Validation of Upstream Processes in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/121/2025 Supersedes SOP/BS/121/2022 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 validation of upstream processes used…

Read More “Biosimilars: SOP for Validation of Upstream Processes – V 2.0” »

Biosimilars V 2.0