Tag: API batch record

API Manufacturing: SOP for Batch Record Documentation and Verification – V 2.0 Standard Operating Procedure for Batch Record Documentation and Verification in API Manufacturing Department API Manufacturing SOP No. SOP/API/035/2025 Supersedes SOP/API/035/2022 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 clear and GMP-compliant…

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API Manufacturing: SOP for Handling of Process Deviations in Manufacturing – V 2.0 Standard Operating Procedure for Handling of Process Deviations in API Manufacturing Department API Manufacturing SOP No. SOP/API/034/2025 Supersedes SOP/API/034/2022 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 identifying,…

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API Manufacturing: SOP for Use of Agitators and Mixing Uniformity Checks – V 2.0 Standard Operating Procedure for Use of Agitators and Mixing Uniformity Checks in API Manufacturing Department API Manufacturing SOP No. SOP/API/033/2025 Supersedes SOP/API/033/2022 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…

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API Manufacturing: SOP for Inert Gas Purging (Nitrogen Blanketing) – V 2.0 Standard Operating Procedure for Inert Gas Purging (Nitrogen Blanketing) in API Manufacturing Department API Manufacturing SOP No. SOP/API/032/2025 Supersedes SOP/API/032/2022 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 standard and safe…

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API Manufacturing: SOP for Work-Up Procedure After Reaction Completion – V 2.0 Standard Operating Procedure for Work-Up Procedure After Reaction Completion in API Manufacturing Department API Manufacturing SOP No. SOP/API/031/2025 Supersedes SOP/API/031/2022 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…

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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…

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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…

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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…

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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…

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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…

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