Tag: API calibration

API Manufacturing: SOP for Handling of Returned Drug Product – V 2.0 Standard Operating Procedure for Handling of Returned Drug Product in API Manufacturing Department API Manufacturing SOP No. SOP/API/178/2025 Supersedes SOP/API/178/2022 Page No. Page 1 of 14 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 Audit Trail Review for GMP Systems – V 2.0 Standard Operating Procedure for Audit Trail Review for GMP Systems in API Manufacturing Department API Manufacturing SOP No. SOP/API/177/2025 Supersedes SOP/API/177/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a standard…

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API Manufacturing: SOP for QA Review of In-Process Control Records – V 2.0 Standard Operating Procedure for QA Review of In-Process Control Records in API Manufacturing Department API Manufacturing SOP No. SOP/API/176/2025 Supersedes SOP/API/176/2022 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 Archival of QA Records and BMRs – V 2.0 Standard Operating Procedure for Archival of QA Records and BMRs in API Manufacturing Department API Manufacturing SOP No. SOP/API/175/2025 Supersedes SOP/API/175/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a documented…

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API Manufacturing: SOP for GMP Training Content Design and Delivery – V 2.0 Standard Operating Procedure for GMP Training Content Design and Delivery in API Manufacturing Department API Manufacturing SOP No. SOP/API/174/2025 Supersedes SOP/API/174/2022 Page No. Page 1 of 14 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 Market Complaint Trending and Evaluation – V 2.0 Standard Operating Procedure for Market Complaint Trending and Evaluation in API Manufacturing Department API Manufacturing SOP No. SOP/API/173/2025 Supersedes SOP/API/173/2022 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…

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API Manufacturing: SOP for Quality Risk Management using FMEA – V 2.0 Standard Operating Procedure for Quality Risk Management using FMEA in API Manufacturing Department API Manufacturing SOP No. SOP/API/172/2025 Supersedes SOP/API/172/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define a systematic approach for…

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API Manufacturing: SOP for SOP Writing, Review, and Approval – V 2.0 Standard Operating Procedure for SOP Writing, Review, and Approval in API Manufacturing Department API Manufacturing SOP No. SOP/API/171/2025 Supersedes SOP/API/171/2022 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 writing,…

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API Manufacturing: SOP for Reprocessing and Rework Authorization – V 2.0 Standard Operating Procedure for Reprocessing and Rework Authorization in API Manufacturing Department API Manufacturing SOP No. SOP/API/170/2025 Supersedes SOP/API/170/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To define the procedure for evaluating, authorizing, executing,…

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API Manufacturing: SOP for Complaint Handling and Investigation – V 2.0 Standard Operating Procedure for Complaint Handling and Investigation in API Manufacturing Department API Manufacturing SOP No. SOP/API/169/2025 Supersedes SOP/API/169/2022 Page No. Page 1 of 14 Issue Date 14/04/2025 Effective Date 16/04/2025 Review Date 14/04/2026 1. Purpose To establish a structured process for receiving, documenting,…

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