Tag: API GMP compliance

API Manufacturing: SOP for Management Review of Quality Metrics – V 2.0 Standard Operating Procedure for Management Review of Quality Metrics in API Manufacturing Department API Manufacturing SOP No. SOP/API/168/2025 Supersedes SOP/API/168/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for conducting…

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API Manufacturing: SOP for Internal Audit Planning and Execution – V 2.0 Standard Operating Procedure for Internal Audit Planning and Execution in API Manufacturing Department API Manufacturing SOP No. SOP/API/167/2025 Supersedes SOP/API/167/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a documented system for…

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API Manufacturing: SOP for Document Control and Distribution – V 2.0 Standard Operating Procedure for Document Control and Distribution in API Manufacturing Department API Manufacturing SOP No. SOP/API/166/2025 Supersedes SOP/API/166/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a systematic procedure for controlling, issuing,…

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API Manufacturing: SOP for Product Quality Review (PQR) Preparation – V 2.0 Standard Operating Procedure for Product Quality Review (PQR) Preparation in API Manufacturing Department API Manufacturing SOP No. SOP/API/165/2025 Supersedes SOP/API/165/2022 Page No. Page 1 of 12 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a standard procedure for…

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API Manufacturing: SOP for Change Control Request Evaluation and Implementation – V 2.0 Standard Operating Procedure for Change Control Request Evaluation and Implementation in API Manufacturing Department API Manufacturing SOP No. SOP/API/164/2025 Supersedes SOP/API/164/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a systematic…

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API Manufacturing: SOP for CAPA (Corrective and Preventive Action) Management – V 2.0 Standard Operating Procedure for CAPA (Corrective and Preventive Action) Management in API Manufacturing Department API Manufacturing SOP No. SOP/API/163/2025 Supersedes SOP/API/163/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a robust…

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API Manufacturing: SOP for Handling Deviations and Incident Reports – V 2.0 Standard Operating Procedure for Handling Deviations and Incident Reports in API Manufacturing Department API Manufacturing SOP No. SOP/API/162/2025 Supersedes SOP/API/162/2022 Page No. Page 1 of 12 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a standardized procedure for…

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API Manufacturing: SOP for Review and Approval of Batch Manufacturing Records (BMR) – V 2.0 Standard Operating Procedure for Review and Approval of Batch Manufacturing Records (BMR) in API Manufacturing Department API Manufacturing SOP No. SOP/API/161/2025 Supersedes SOP/API/161/2022 Page No. Page 1 of 13 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose…

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API Manufacturing: SOP for Cleaning and Shutdown of QC Equipment – V 2.0 Standard Operating Procedure for Cleaning and Shutdown of QC Equipment in API Manufacturing Department API Manufacturing SOP No. SOP/API/160/2025 Supersedes SOP/API/160/2022 Page No. Page 1 of 12 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a systematic…

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API Manufacturing: SOP for Monthly Verification of QC Working Standards – V 2.0 Standard Operating Procedure for Monthly Verification of QC Working Standards in API Manufacturing Department API Manufacturing SOP No. SOP/API/159/2025 Supersedes SOP/API/159/2022 Page No. Page 1 of 11 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a standard…

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