Tag: Good Laboratory Practice (GLP)

BA-BE Studies: SOP for Selectivity and Sensitivity Evaluation – V 2.0 Standard Operating Procedure for Selectivity and Sensitivity Evaluation in BA/BE Method Validation Department BA-BE Studies SOP No. SOP/BA-BE/180/2025 Supersedes SOP/BA-BE/180/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a standardized procedure for evaluating…

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BA-BE Studies: SOP for Matrix Effect Assessment – V 2.0 Standard Operating Procedure for Matrix Effect Assessment in BA/BE Bioanalytical Method Validation Department BA-BE Studies SOP No. SOP/BA-BE/179/2025 Supersedes SOP/BA-BE/179/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To describe the procedure for evaluating the matrix…

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BA-BE Studies: SOP for Auto-sampler Stability of Samples – V 2.0 Standard Operating Procedure for Auto-sampler Stability of Analyte in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/178/2025 Supersedes SOP/BA-BE/178/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for evaluating the auto-sampler…

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BA-BE Studies: SOP for Bench-Top Stability Evaluation – V 2.0 Standard Operating Procedure for Bench-Top Stability Evaluation of Analyte in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/177/2025 Supersedes SOP/BA-BE/177/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for evaluating bench-top stability…

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BA-BE Studies: SOP for Long-Term Storage Stability of Analyte – V 2.0 Standard Operating Procedure for Long-Term Storage Stability of Analyte in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/176/2025 Supersedes SOP/BA-BE/176/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for assessing…

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BA-BE Studies: SOP for Short-Term Stability of Analyte – V 2.0 Standard Operating Procedure for Short-Term Stability of Analyte in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/175/2025 Supersedes SOP/BA-BE/175/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for conducting short-term stability…

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BA-BE Studies: SOP for Freeze-Thaw Stability Studies – V 2.0 Standard Operating Procedure for Conducting Freeze-Thaw Stability Studies in BA/BE Analysis Department BA-BE Studies SOP No. SOP/BA-BE/174/2025 Supersedes SOP/BA-BE/174/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the process for conducting freeze-thaw stability studies…

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BA-BE Studies: SOP for Stability Testing of Analyte in Plasma – V 2.0 Standard Operating Procedure for Stability Testing of Analyte in Plasma for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/173/2025 Supersedes SOP/BA-BE/173/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure…

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BA-BE Studies: SOP for Review of Calibration Curve and QC Acceptance – V 2.0 Standard Operating Procedure for Review of Calibration Curve and QC Acceptance in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/172/2025 Supersedes SOP/BA-BE/172/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish…

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BA-BE Studies: SOP for Handling Bioanalytical Raw Data Files – V 2.0 Standard Operating Procedure for Handling Bioanalytical Raw Data Files in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/171/2025 Supersedes SOP/BA-BE/171/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a standardized procedure for…

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