Author: Auditor

Creams: SOP for Odor Stability Testing in Cream Formulations – V 2.0

Creams: SOP for Odor Stability Testing in Cream Formulations – V 2.0 Standard Operating Procedure for Odor Stability Testing in Cream Formulations Department Creams SOP No. SOP/CRM/139/2025 Supersedes SOP/CRM/139/2022 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

BA-BE Studies: SOP for Environmental Monitoring in Volunteer Areas – V 2.0

BA-BE Studies: SOP for Environmental Monitoring in Volunteer Areas – V 2.0 Standard Operating Procedure for Environmental Monitoring in Volunteer Areas during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/117/2025 Supersedes SOP/BA-BE/117/2022 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 the procedure for systematic…

BA-BE Studies V 2.0

API Manufacturing: SOP for IPC Sample Retention Procedure – V 2.0

API Manufacturing: SOP for IPC Sample Retention Procedure – V 2.0 Standard Operating Procedure for IPC Sample Retention Procedure in API Manufacturing Department API Manufacturing SOP No. SOP/API/098/2025 Supersedes SOP/API/098/2022 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 the collection, labeling,…

API Manufacturing V 2.0

Analytical Method Development: Titrimetric Assay Development for Acidity – V 2.0

Analytical Method Development: Titrimetric Assay Development for Acidity – V 2.0 SOP for Titrimetric Assay Development for Acidity in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/044/2025 Supersedes SOP/AMD/044/2022 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 developing,…

Analytical Method Development V 2.0

Elixir Department: SOP for Use of Material Transfer Hatches – V 2.0

Elixir Department: SOP for Use of Material Transfer Hatches – V 2.0 Standard Operating Procedure for Use of Material Transfer Hatches in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/042/2025 Supersedes SOP/ELX/042/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose This SOP defines the procedure for…

Elixers V 2.0

Aerosol: SOP for Revalidating Equipment After Maintenance – V 2.0

Aerosol: SOP for Revalidating Equipment After Maintenance – V 2.0 SOP for Revalidating Equipment After Maintenance Department Aerosol SOP No. SOP/Aerosol/139/2025 Supersedes SOP/Aerosol/139/2022 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 revalidating…

Aerosols V 2.0

Biosimilars: SOP for Deviation Handling During Clone Development – V 2.0

Biosimilars: SOP for Deviation Handling During Clone Development – V 2.0 Standard Operating Procedure for Deviation Handling During Clone Development in Biosimilars Department Biosimilars SOP No. SOP/BS/050/2025 Supersedes SOP/BS/050/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline a systematic process for identifying, documenting, investigating,…

Biosimilars V 2.0

BA-BE Studies: SOP for Preventive Maintenance of Clinical Equipment – V 2.0

BA-BE Studies: SOP for Preventive Maintenance of Clinical Equipment – V 2.0 Standard Operating Procedure for Preventive Maintenance of Clinical Equipment in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/116/2025 Supersedes SOP/BA-BE/116/2022 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 procedure for…

BA-BE Studies V 2.0

API Manufacturing: SOP for Sampling of Toxic and Potent Compounds – V 2.0

API Manufacturing: SOP for Sampling of Toxic and Potent Compounds – V 2.0 Standard Operating Procedure for Sampling of Toxic and Potent Compounds in API Manufacturing Department API Manufacturing SOP No. SOP/API/097/2025 Supersedes SOP/API/097/2022 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 a safe,…

API Manufacturing V 2.0

Analytical Method Development: pH Method Development for Formulations – V 2.0

Analytical Method Development: pH Method Development for Formulations – V 2.0 SOP for pH Method Development of Pharmaceutical Formulations in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/043/2025 Supersedes SOP/AMD/043/2022 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 process for developing…

Analytical Method Development V 2.0