Tag: Therapeutic equivalence

BA-BE Studies: SOP for Document Control in Clinical Phase – V 2.0 Standard Operating Procedure for Document Control during Clinical Phase of BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/120/2025 Supersedes SOP/BA-BE/120/2022 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 systematic and compliant…

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BA-BE Studies: SOP for Securing and Tracking of Biological Waste – V 2.0 Standard Operating Procedure for Securing and Tracking of Biological Waste in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/119/2025 Supersedes SOP/BA-BE/119/2022 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 a standardized…

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BA-BE Studies: SOP for Cleaning and Disinfection of Dosing Rooms – V 2.0 Standard Operating Procedure for Cleaning and Disinfection of Dosing Rooms in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/118/2025 Supersedes SOP/BA-BE/118/2022 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 standardized…

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BA-BE Studies: SOP for Environmental Monitoring in Volunteer Areas – V 2.0 Standard Operating Procedure for Environmental Monitoring in Volunteer Areas during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/117/2025 Supersedes SOP/BA-BE/117/2022 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 systematic…

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BA-BE Studies: SOP for Preventive Maintenance of Clinical Equipment – V 2.0 Standard Operating Procedure for Preventive Maintenance of Clinical Equipment in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/116/2025 Supersedes SOP/BA-BE/116/2022 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…

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BA-BE Studies: SOP for Documenting Protocol Violations and CAPA – V 2.0 Standard Operating Procedure for Documenting Protocol Violations and CAPA in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/115/2025 Supersedes SOP/BA-BE/115/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a uniform process for…

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BA-BE Studies: SOP for Preventing Cross-Contamination of Samples – V 2.0 Standard Operating Procedure for Preventing Cross-Contamination of Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/114/2025 Supersedes SOP/BA-BE/114/2022 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 a robust and standardized procedure for…

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BA-BE Studies: SOP for Transfer of Samples from Satellite Clinics – V 2.0 Standard Operating Procedure for Transfer of Samples from Satellite Clinics in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/113/2025 Supersedes SOP/BA-BE/113/2022 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…

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BA-BE Studies: SOP for Handling Cold Chain Breaches During Sample Storage – V 2.0 Standard Operating Procedure for Handling Cold Chain Breaches During Sample Storage in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/112/2025 Supersedes SOP/BA-BE/112/2022 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…

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BA-BE Studies: SOP for Ensuring Compliance with Schedule Y Clinical Requirements – V 2.0 Standard Operating Procedure for Ensuring Compliance with Schedule Y Clinical Requirements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/111/2025 Supersedes SOP/BA-BE/111/2022 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…

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