Author: Auditor

BA-BE Studies: SOP for Handling Cold Chain Breaches During Sample Storage – V 2.0

BA-BE Studies: SOP for Handling Cold Chain Breaches During Sample Storage – V 2.0 Standard Operating Procedure for Handling Cold Chain Breaches During Sample Storage in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/112/2025 Supersedes SOP/BA-BE/112/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…

BA-BE Studies V 2.0

Analytical Method Development: Archiving Method Development Reports – V 2.0

Analytical Method Development: Archiving Method Development Reports – V 2.0 SOP for Archiving Analytical Method Development Reports in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/039/2025 Supersedes SOP/AMD/039/2022 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 describes the procedure for the review,…

Analytical Method Development V 2.0

Creams: SOP for Conducting FTIR Analysis of Cream Ingredients – V 2.0

Creams: SOP for Conducting FTIR Analysis of Cream Ingredients – V 2.0 Standard Operating Procedure for Conducting FTIR Analysis of Cream Ingredients Department Creams SOP No. SOP/CRM/136/2025 Supersedes SOP/CRM/136/2022 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

Aerosol: SOP for Validating Mixing Tanks Used in Formulation – V 2.0

Aerosol: SOP for Validating Mixing Tanks Used in Formulation – V 2.0 SOP for Validating Mixing Tanks Used in Formulation Department Aerosol SOP No. SOP/Aerosol/137/2025 Supersedes SOP/Aerosol/137/2022 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…

Aerosols V 2.0

API Manufacturing: SOP for Management of IPC Outliers and Investigations – V 2.0

API Manufacturing: SOP for Management of IPC Outliers and Investigations – V 2.0 Standard Operating Procedure for Management of IPC Outliers and Investigations in API Manufacturing Department API Manufacturing SOP No. SOP/API/092/2025 Supersedes SOP/API/092/2022 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

Elixir Department: SOP for Dispensing of Preservatives for Elixirs – V 2.0

Elixir Department: SOP for Dispensing of Preservatives for Elixirs – V 2.0 Standard Operating Procedure for Dispensing of Preservatives in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/038/2025 Supersedes SOP/ELX/038/2022 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 the safe,…

Elixers V 2.0

Analytical Method Development: Handling of AMD Method Notebooks – V 2.0

Analytical Method Development: Handling of AMD Method Notebooks – V 2.0 SOP for Handling Method Development Notebooks in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/038/2025 Supersedes SOP/AMD/038/2022 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 describes the procedures for the issuance,…

Analytical Method Development V 2.0

BA-BE Studies: SOP for Ensuring Compliance with Schedule Y Clinical Requirements – V 2.0

BA-BE Studies: SOP for Ensuring Compliance with Schedule Y Clinical Requirements – V 2.0 Standard Operating Procedure for Ensuring Compliance with Schedule Y Clinical Requirements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/111/2025 Supersedes SOP/BA-BE/111/2022 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…

BA-BE Studies V 2.0

Biosimilars: SOP for Use and Maintenance of Biosafety Cabinets – V 2.0

Biosimilars: SOP for Use and Maintenance of Biosafety Cabinets – V 2.0 Standard Operating Procedure for Use and Maintenance of Biosafety Cabinets in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/046/2025 Supersedes SOP/BS/046/2022 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 standardized procedures for the…

Biosimilars V 2.0

API Manufacturing: SOP for Sampling Frequency and Quantity Guidelines – V 2.0

API Manufacturing: SOP for Sampling Frequency and Quantity Guidelines – V 2.0 Standard Operating Procedure for Sampling Frequency and Quantity Guidelines in API Manufacturing Department API Manufacturing SOP No. SOP/API/091/2025 Supersedes SOP/API/091/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish uniform guidelines for the…

API Manufacturing V 2.0