Tag: API BMR

API Manufacturing: SOP for Operation of FTIR Spectrometer – V 2.0

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API Manufacturing: SOP for Operation of FTIR Spectrometer – V 2.0 Standard Operating Procedure for Operation of FTIR Spectrometer in API Manufacturing Department API Manufacturing SOP No. SOP/API/148/2025 Supersedes SOP/API/148/2022 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 detailed instructions for the proper and…

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API Manufacturing: SOP for Review of Chromatograms and Peak Integration – V 2.0

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API Manufacturing: SOP for Review of Chromatograms and Peak Integration – V 2.0 Standard Operating Procedure for Review of Chromatograms and Peak Integration in API Manufacturing Department API Manufacturing SOP No. SOP/API/147/2025 Supersedes SOP/API/147/2022 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 standardized…

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API Manufacturing: SOP for Reanalysis Protocol for Failed Samples – V 2.0

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API Manufacturing: SOP for Reanalysis Protocol for Failed Samples – V 2.0 Standard Operating Procedure for Reanalysis Protocol for Failed Samples in API Manufacturing Department API Manufacturing SOP No. SOP/API/146/2025 Supersedes SOP/API/146/2022 Page No. Page 1 of 9 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a scientifically sound and…

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API Manufacturing: SOP for Handling of Incidental Lab Spills – V 2.0

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API Manufacturing: SOP for Handling of Incidental Lab Spills – V 2.0 Standard Operating Procedure for Handling of Incidental Lab Spills in API Manufacturing Department API Manufacturing SOP No. SOP/API/145/2025 Supersedes SOP/API/145/2022 Page No. Page 1 of 7 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standardized procedure for…

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API Manufacturing: SOP for Testing of API Intermediates and Final Batch – V 2.0

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API Manufacturing: SOP for Testing of API Intermediates and Final Batch – V 2.0 Standard Operating Procedure for Testing of API Intermediates and Final Batch Department API Manufacturing SOP No. SOP/API/144/2025 Supersedes SOP/API/144/2022 Page No. Page 1 of 9 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a detailed procedure…

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API Manufacturing: SOP for Review and Archiving of Analytical Data – V 2.0

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API Manufacturing: SOP for Review and Archiving of Analytical Data – V 2.0 Standard Operating Procedure for Review and Archiving of Analytical Data in API Manufacturing Department API Manufacturing SOP No. SOP/API/143/2025 Supersedes SOP/API/143/2022 Page No. Page 1 of 8 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a uniform…

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API Manufacturing: SOP for Analytical Method Transfer to QC – V 2.0

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API Manufacturing: SOP for Analytical Method Transfer to QC – V 2.0 Standard Operating Procedure for Analytical Method Transfer to Quality Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/142/2025 Supersedes SOP/API/142/2022 Page No. Page 1 of 9 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a structured process…

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API Manufacturing: SOP for Review of Analytical Test Reports – V 2.0

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API Manufacturing: SOP for Review of Analytical Test Reports – V 2.0 Standard Operating Procedure for Review of Analytical Test Reports in API Manufacturing Department API Manufacturing SOP No. SOP/API/141/2025 Supersedes SOP/API/141/2022 Page No. Page 1 of 7 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To provide a clear and structured…

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API Manufacturing: SOP for Preparation of Volumetric Solutions – V 2.0

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API Manufacturing: SOP for Preparation of Volumetric Solutions – V 2.0 Standard Operating Procedure for Preparation of Volumetric Solutions in API Manufacturing Department API Manufacturing SOP No. SOP/API/140/2025 Supersedes SOP/API/140/2022 Page No. Page 1 of 8 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a uniform procedure for the preparation,…

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API Manufacturing: SOP for Sample Disposal After Analysis – V 2.0

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API Manufacturing: SOP for Sample Disposal After Analysis – V 2.0 Standard Operating Procedure for Sample Disposal After Analysis in API Manufacturing Department API Manufacturing SOP No. SOP/API/139/2025 Supersedes SOP/API/139/2022 Page No. Page 1 of 7 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a systematic procedure for the safe,…

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API Manufacturing V 2.0