Author: Auditor

API Manufacturing: SOP for Sample Preservation for Investigation Purpose – V 2.0

API Manufacturing: SOP for Sample Preservation for Investigation Purpose – V 2.0 Standard Operating Procedure for Sample Preservation for Investigation Purpose in API Manufacturing Department API Manufacturing SOP No. SOP/API/118/2025 Supersedes SOP/API/118/2022 Page No. Page 1 of 9 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard method for…

API Manufacturing V 2.0

Elixir Department: SOP for Use of Water for Injection (WFI) in Elixir Production – V 2.0

Elixir Department: SOP for Use of Water for Injection (WFI) in Elixir Production – V 2.0 Standard Operating Procedure for Use of Water for Injection (WFI) in Elixir Production Department Elixir Department SOP No. SOP/ELX/058/2025 Supersedes SOP/ELX/058/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To…

Elixers V 2.0

BA-BE Studies: SOP for Emergency Protocol Activation – V 2.0

BA-BE Studies: SOP for Emergency Protocol Activation – V 2.0 Standard Operating Procedure for Emergency Protocol Activation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/134/2025 Supersedes SOP/BA-BE/134/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a clear and effective procedure for the activation…

BA-BE Studies V 2.0

Analytical Method Development: Gas Evolution Reaction Method – V 2.0

Analytical Method Development: Gas Evolution Reaction Method – V 2.0 SOP for Gas Evolution Reaction-Based Analytical Method in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/061/2025 Supersedes SOP/AMD/061/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose The purpose of this SOP is to establish a…

Analytical Method Development V 2.0

Aerosol: SOP for Documenting Utility Validation Data – V 2.0

Aerosol: SOP for Documenting Utility Validation Data – V 2.0 SOP for Documenting Utility Validation Data Department Aerosol SOP No. SOP/Aerosol/147/2025 Supersedes SOP/Aerosol/147/2022 Page No. Page 1 of Y Issue Date 06/02/2025 Effective Date 16/02/2025 Review Date 06/02/2028 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for documenting…

Aerosols V 2.0

API Manufacturing: SOP for IPC Sign-Off on Batch Manufacturing Record – V 2.0

API Manufacturing: SOP for IPC Sign-Off on Batch Manufacturing Record – V 2.0 Standard Operating Procedure for IPC Sign-Off on Batch Manufacturing Record in API Manufacturing Department API Manufacturing SOP No. SOP/API/117/2025 Supersedes SOP/API/117/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the procedure…

API Manufacturing V 2.0

Biosimilars: SOP for Use of Chemically Defined Media – V 2.0

Biosimilars: SOP for Use of Chemically Defined Media – V 2.0 Standard Operating Procedure for Use of Chemically Defined Media in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/063/2025 Supersedes SOP/BS/063/2022 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 procedure for selection, preparation,…

Biosimilars V 2.0

BA-BE Studies: SOP for Management of Trial Equipment Calibration Logs – V 2.0

BA-BE Studies: SOP for Management of Trial Equipment Calibration Logs – V 2.0 Standard Operating Procedure for Management of Trial Equipment Calibration Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/133/2025 Supersedes SOP/BA-BE/133/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a standardized…

BA-BE Studies V 2.0

Analytical Method Development: Oxidation-Reduction Titration Development – V 2.0

Analytical Method Development: Oxidation-Reduction Titration Development – V 2.0 SOP for Oxidation-Reduction Titration Method Development in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/060/2025 Supersedes SOP/AMD/060/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP provides detailed instructions for the development, optimization, and validation…

Analytical Method Development V 2.0

Creams: SOP for Dissolution Testing of Cream Products – V 2.0

Creams: SOP for Dissolution Testing of Cream Products – V 2.0 Standard Operating Procedure for Dissolution Testing of Cream Products Department Creams SOP No. SOP/CRM/147/2025 Supersedes SOP/CRM/147/2022 Page No. Page 1 of 5 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to outline the procedure for…

Creams V 2.0