Author: Auditor

Elixir Department: SOP for Maintaining Volume Adjustments – V 2.0

Elixir Department: SOP for Maintaining Volume Adjustments – V 2.0 Standard Operating Procedure for Maintaining Volume Adjustments in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/059/2025 Supersedes SOP/ELX/059/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standard procedure for accurately adjusting the final…

Elixers V 2.0

API Manufacturing: SOP for IPC Limits Setting and Justification – V 2.0

API Manufacturing: SOP for IPC Limits Setting and Justification – V 2.0 Standard Operating Procedure for IPC Limits Setting and Justification in API Manufacturing Department API Manufacturing SOP No. SOP/API/119/2025 Supersedes SOP/API/119/2022 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 for setting…

API Manufacturing V 2.0

BA-BE Studies: SOP for Clinical Supply Label Review and Approval – V 2.0

BA-BE Studies: SOP for Clinical Supply Label Review and Approval – V 2.0 Standard Operating Procedure for Clinical Supply Label Review and Approval in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/135/2025 Supersedes SOP/BA-BE/135/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a uniform…

BA-BE Studies V 2.0

Analytical Method Development: Moisture Analysis Method for Hygroscopic APIs – V 2.0

Analytical Method Development: Moisture Analysis Method for Hygroscopic APIs – V 2.0 SOP for Moisture Determination in Hygroscopic Active Pharmaceutical Ingredients Department Analytical Method Development SOP No. SOP/AMD/062/2025 Supersedes SOP/AMD/062/2022 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 establishes the procedure for the development,…

Analytical Method Development V 2.0

Biosimilars: SOP for Setup and Sterilization of Bioreactor Vessels – V 2.0

Biosimilars: SOP for Setup and Sterilization of Bioreactor Vessels – V 2.0 Standard Operating Procedure for Setup and Sterilization of Bioreactor Vessels in Biosimilar Production Department Biosimilars SOP No. SOP/BS/064/2025 Supersedes SOP/BS/064/2022 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…

Biosimilars V 2.0

Creams: SOP for Ensuring Batch-to-Batch Consistency in Cream Manufacturing – V 2.0

Creams: SOP for Ensuring Batch-to-Batch Consistency in Cream Manufacturing – V 2.0 Standard Operating Procedure for Ensuring Batch-to-Batch Consistency in Cream Manufacturing Department Creams SOP No. SOP/CRM/148/2025 Supersedes SOP/CRM/148/2022 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 define the…

Creams V 2.0

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