Tag: API validation

API Manufacturing: SOP for Sieve Integrity Verification – V 2.0 Standard Operating Procedure for Sieve Integrity Verification in API Manufacturing Department API Manufacturing SOP No. SOP/API/069/2025 Supersedes SOP/API/069/2022 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 verifying the physical integrity of…

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API Manufacturing: SOP for Particle Size Distribution Monitoring – V 2.0 Standard Operating Procedure for Particle Size Distribution Monitoring in API Manufacturing Department API Manufacturing SOP No. SOP/API/068/2025 Supersedes SOP/API/068/2022 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 monitoring particle size…

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API Manufacturing: SOP for Jet Milling Operation – V 2.0 Standard Operating Procedure for Jet Milling Operation in API Manufacturing Department API Manufacturing SOP No. SOP/API/067/2025 Supersedes SOP/API/067/2022 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 procedure for jet milling operations in…

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API Manufacturing: SOP for Moisture Content Analysis by LOD – V 2.0 Standard Operating Procedure for Moisture Content Analysis by Loss on Drying (LOD) in API Manufacturing Department API Manufacturing SOP No. SOP/API/066/2025 Supersedes SOP/API/066/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To provide a…

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API Manufacturing: SOP for Vacuum Drying Procedure – V 2.0 Standard Operating Procedure for Vacuum Drying Procedure in API Manufacturing Department API Manufacturing SOP No. SOP/API/065/2025 Supersedes SOP/API/065/2022 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 and validated procedure for drying active…

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API Manufacturing: SOP for Tray Loading for Drying – V 2.0 Standard Operating Procedure for Tray Loading for Drying in API Manufacturing Department API Manufacturing SOP No. SOP/API/064/2025 Supersedes SOP/API/064/2022 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 tray loading of…

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API Manufacturing: SOP for Polymorph Screening Method – V 2.0 Standard Operating Procedure for Polymorph Screening Method in API Manufacturing Department API Manufacturing SOP No. SOP/API/063/2025 Supersedes SOP/API/063/2022 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 and scientifically robust procedure for polymorph…

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API Manufacturing: SOP for Seeding Techniques in Crystallization – V 2.0 Standard Operating Procedure for Seeding Techniques in Crystallization in API Manufacturing Department API Manufacturing SOP No. SOP/API/062/2025 Supersedes SOP/API/062/2022 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 procedure for implementing seeding…

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API Manufacturing: SOP for Crystallization Process Control – V 2.0 Standard Operating Procedure for Crystallization Process Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/061/2025 Supersedes SOP/API/061/2022 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 and validated procedure for carrying out…

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API Manufacturing: SOP for Use of Cooling Towers and Condensers in Recovery – V 2.0 Standard Operating Procedure for Use of Cooling Towers and Condensers in Recovery Process in API Manufacturing Department API Manufacturing SOP No. SOP/API/060/2025 Supersedes SOP/API/060/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1….

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