Author: Auditor

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

Creams: SOP for Preservative Efficacy Testing of Creams – V 2.0

Creams: SOP for Preservative Efficacy Testing of Creams – V 2.0 Standard Operating Procedure for Preservative Efficacy Testing of Creams Department Creams SOP No. SOP/CRM/135/2025 Supersedes SOP/CRM/135/2022 Page No. Page 1 of 6 Issue Date 21/01/2026 Effective Date 26/01/2026 Review Date 21/01/2027 1. Purpose The purpose of this SOP is to establish a standard procedure…

Creams V 2.0

Analytical Method Development: Data Integrity in Method Development – V 2.0

Analytical Method Development: Data Integrity in Method Development – V 2.0 SOP for Ensuring Data Integrity During Analytical Method Development Activities Department Analytical Method Development SOP No. SOP/AMD/037/2025 Supersedes SOP/AMD/037/2022 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 outlines the principles and procedures required…

Analytical Method Development V 2.0

BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0

BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0 Standard Operating Procedure for Reconciliation of Clinical Sample Volumes in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/110/2025 Supersedes SOP/BA-BE/110/2022 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 systematic procedure for…

BA-BE Studies V 2.0

Elixir Department: SOP for Double Check System During Material Dispensing – V 2.0

Elixir Department: SOP for Double Check System During Material Dispensing – V 2.0 Standard Operating Procedure for Double Check System During Dispensing of Materials Department Elixir Department SOP No. SOP/ELX/037/2025 Supersedes SOP/ELX/037/2022 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 establishes the procedure for…

Elixers V 2.0

API Manufacturing: SOP for Real-Time Yield Monitoring During Reactions – V 2.0

API Manufacturing: SOP for Real-Time Yield Monitoring During Reactions – V 2.0 Standard Operating Procedure for Real-Time Yield Monitoring During Reactions in API Manufacturing Department API Manufacturing SOP No. SOP/API/090/2025 Supersedes SOP/API/090/2022 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 real-time…

API Manufacturing V 2.0

Aerosol: SOP for Validating Temperature Sensors in Aerosol Manufacturing – V 2.0

Aerosol: SOP for Validating Temperature Sensors in Aerosol Manufacturing – V 2.0 SOP for Validating Temperature Sensors in Aerosol Manufacturing Department Aerosol SOP No. SOP/Aerosol/136/2025 Supersedes SOP/Aerosol/136/2022 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 provide…

Aerosols V 2.0

Biosimilars: SOP for Monitoring CO₂ Levels in Incubators – V 2.0

Biosimilars: SOP for Monitoring CO₂ Levels in Incubators – V 2.0 Standard Operating Procedure for Monitoring CO₂ Levels in Incubators in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/045/2025 Supersedes SOP/BS/045/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the routine procedure for monitoring and…

Biosimilars V 2.0

Analytical Method Development: Reagent Qualification for Method Development – V 2.0

Analytical Method Development: Reagent Qualification for Method Development – V 2.0 SOP for Qualification of Reagents Used in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/036/2025 Supersedes SOP/AMD/036/2022 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 defines the procedure for qualifying reagents…

Analytical Method Development V 2.0

BA-BE Studies: SOP for Clinical Trial Photography and Video Recording – V 2.0

BA-BE Studies: SOP for Clinical Trial Photography and Video Recording – V 2.0 Standard Operating Procedure for Clinical Trial Photography and Video Recording in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/109/2025 Supersedes SOP/BA-BE/109/2022 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 controlled…

BA-BE Studies V 2.0