Tag: API centrifuge

API Manufacturing: SOP for QA Role in Cleaning Validation – V 2.0

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API Manufacturing: SOP for QA Role in Cleaning Validation – V 2.0 Standard Operating Procedure for QA Role in Cleaning Validation in API Manufacturing Department API Manufacturing SOP No. SOP/API/198/2025 Supersedes SOP/API/198/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the role of the…

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API Manufacturing: SOP for Preparation of Quality Metrics Dashboard – V 2.0

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API Manufacturing: SOP for Preparation of Quality Metrics Dashboard – V 2.0 Standard Operating Procedure for Preparation of Quality Metrics Dashboard in API Manufacturing Department API Manufacturing SOP No. SOP/API/197/2025 Supersedes SOP/API/197/2022 Page No. Page 1 of 16 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for compiling,…

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API Manufacturing: SOP for Issuance of Controlled Copies of SOPs – V 2.0

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API Manufacturing: SOP for Issuance of Controlled Copies of SOPs – V 2.0 Standard Operating Procedure for Issuance of Controlled Copies of SOPs in API Manufacturing Department API Manufacturing SOP No. SOP/API/196/2025 Supersedes SOP/API/196/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure…

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API Manufacturing: SOP for Management of Temporary Procedure Changes – V 2.0

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API Manufacturing: SOP for Management of Temporary Procedure Changes – V 2.0 Standard Operating Procedure for Management of Temporary Procedure Changes in API Manufacturing Department API Manufacturing SOP No. SOP/API/195/2025 Supersedes SOP/API/195/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a controlled process for…

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API Manufacturing: SOP for Preparation of Site Master File (SMF) – V 2.0

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API Manufacturing: SOP for Preparation of Site Master File (SMF) – V 2.0 Standard Operating Procedure for Preparation of Site Master File (SMF) in API Manufacturing Department API Manufacturing SOP No. SOP/API/194/2025 Supersedes SOP/API/194/2022 Page No. Page 1 of 16 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To provide a documented…

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API Manufacturing: SOP for Control of Electronic QA Documentation – V 2.0

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API Manufacturing: SOP for Control of Electronic QA Documentation – V 2.0 Standard Operating Procedure for Control of Electronic QA Documentation in API Manufacturing Department API Manufacturing SOP No. SOP/API/193/2025 Supersedes SOP/API/193/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a procedure for the…

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API Manufacturing: SOP for Risk-Based Inspection Planning – V 2.0

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API Manufacturing: SOP for Risk-Based Inspection Planning – V 2.0 Standard Operating Procedure for Risk-Based Inspection Planning in API Manufacturing Department API Manufacturing SOP No. SOP/API/192/2025 Supersedes SOP/API/192/2022 Page No. Page 1 of 16 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a standardized approach for planning inspections based on…

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API Manufacturing: SOP for Approval of Analytical Methods and Specifications – V 2.0

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API Manufacturing: SOP for Approval of Analytical Methods and Specifications – V 2.0 Standard Operating Procedure for Approval of Analytical Methods and Specifications in API Manufacturing Department API Manufacturing SOP No. SOP/API/191/2025 Supersedes SOP/API/191/2022 Page No. Page 1 of 16 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 Review of Product Labels and Packaging Materials – V 2.0

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API Manufacturing: SOP for Review of Product Labels and Packaging Materials – V 2.0 Standard Operating Procedure for Review of Product Labels and Packaging Materials in API Manufacturing Department API Manufacturing SOP No. SOP/API/190/2025 Supersedes SOP/API/190/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define…

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API Manufacturing: SOP for Review of Validation Protocols and Reports – V 2.0

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API Manufacturing: SOP for Review of Validation Protocols and Reports – V 2.0 Standard Operating Procedure for Review of Validation Protocols and Reports in API Manufacturing Department API Manufacturing SOP No. SOP/API/189/2025 Supersedes SOP/API/189/2022 Page No. Page 1 of 15 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure…

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API Manufacturing V 2.0