Tag: API manufacturing

API Manufacturing: SOP for Process Yield Calculation and Documentation – V 2.0 Standard Operating Procedure for Process Yield Calculation and Documentation in API Manufacturing Department API Manufacturing SOP No. SOP/API/030/2025 Supersedes SOP/API/030/2022 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 standardized and GMP-compliant…

Read More “API Manufacturing: SOP for Process Yield Calculation and Documentation – V 2.0” »

API Manufacturing: SOP for Transfer of Wet Cake for Drying – V 2.0 Standard Operating Procedure for Transfer of Wet Cake for Drying in API Manufacturing Department API Manufacturing SOP No. SOP/API/029/2025 Supersedes SOP/API/029/2022 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 standard…

Read More “API Manufacturing: SOP for Transfer of Wet Cake for Drying – V 2.0” »

API Manufacturing: SOP for Recrystallization for API Purification – V 2.0 Standard Operating Procedure for Recrystallization for API Purification in API Manufacturing Department API Manufacturing SOP No. SOP/API/028/2025 Supersedes SOP/API/028/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a standardized procedure for the recrystallization…

Read More “API Manufacturing: SOP for Recrystallization for API Purification – V 2.0” »

API Manufacturing: SOP for Centrifugation Process for Wet Cake Separation – V 2.0 Standard Operating Procedure for Centrifugation Process for Wet Cake Separation in API Manufacturing Department API Manufacturing SOP No. SOP/API/027/2025 Supersedes SOP/API/027/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To describe the procedure…

Read More “API Manufacturing: SOP for Centrifugation Process for Wet Cake Separation – V 2.0” »

API Manufacturing: SOP for Isolation by Filtration – V 2.0 Standard Operating Procedure for Isolation by Filtration in API Manufacturing Department API Manufacturing SOP No. SOP/API/026/2025 Supersedes SOP/API/026/2022 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 a standard procedure for the isolation of solid…

Read More “API Manufacturing: SOP for Isolation by Filtration – V 2.0” »

API Manufacturing: SOP for Phase Separation Techniques – V 2.0 Standard Operating Procedure for Phase Separation Techniques in API Manufacturing Department API Manufacturing SOP No. SOP/API/025/2025 Supersedes SOP/API/025/2022 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 a procedure for conducting phase separation efficiently and…

Read More “API Manufacturing: SOP for Phase Separation Techniques – V 2.0” »

API Manufacturing: SOP for Handling of Exothermic Reactions – V 2.0 Standard Operating Procedure for Handling of Exothermic Reactions in API Manufacturing Department API Manufacturing SOP No. SOP/API/024/2025 Supersedes SOP/API/024/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the procedure for the safe handling…

Read More “API Manufacturing: SOP for Handling of Exothermic Reactions – V 2.0” »

API Manufacturing: SOP for Use of Jacketed Reactors with Temperature Control – V 2.0 Standard Operating Procedure for Use of Jacketed Reactors with Temperature Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/023/2025 Supersedes SOP/API/023/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define…

Read More “API Manufacturing: SOP for Use of Jacketed Reactors with Temperature Control – V 2.0” »

API Manufacturing: SOP for Monitoring of Reaction Parameters – V 2.0 Standard Operating Procedure for Monitoring of Reaction Parameters in API Manufacturing Department API Manufacturing SOP No. SOP/API/022/2025 Supersedes SOP/API/022/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a procedure for consistent and controlled…

Read More “API Manufacturing: SOP for Monitoring of Reaction Parameters – V 2.0” »

API Manufacturing: SOP for Charging of Materials into Reactor – V 2.0 Standard Operating Procedure for Charging of Materials into Reactor in API Manufacturing Department API Manufacturing SOP No. SOP/API/021/2025 Supersedes SOP/API/021/2022 Page No. Page 1 of 11 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standardized procedure for…

Read More “API Manufacturing: SOP for Charging of Materials into Reactor – V 2.0” »