The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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…
BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0 Standard Operating Procedure for Reconciliation of Clinical Sample Volumes in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/110/2025 Supersedes SOP/BA-BE/110/2022 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 systematic procedure for…
Read More “BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0” »
BA-BE Studies: SOP for Clinical Trial Photography and Video Recording – V 2.0 Standard Operating Procedure for Clinical Trial Photography and Video Recording in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/109/2025 Supersedes SOP/BA-BE/109/2022 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 controlled…
Read More “BA-BE Studies: SOP for Clinical Trial Photography and Video Recording – V 2.0” »
BA-BE Studies: SOP for Use of Controlled Substances in BE Studies – V 2.0 Standard Operating Procedure for Use of Controlled Substances in Bioequivalence (BE) Studies Department BA-BE Studies SOP No. SOP/BA-BE/108/2025 Supersedes SOP/BA-BE/108/2022 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 the procedure…
Read More “BA-BE Studies: SOP for Use of Controlled Substances in BE Studies – V 2.0” »
BA-BE Studies: SOP for Managing Subject Dropouts and Replacements in BA/BE Studies – V 2.0 Standard Operating Procedure for Managing Subject Dropouts and Replacements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/107/2025 Supersedes SOP/BA-BE/107/2022 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…
BA-BE Studies: SOP for Managing Female Volunteers in BA/BE Trials – V 2.0 Standard Operating Procedure for Managing Female Volunteers in BA/BE Trials Department BA-BE Studies SOP No. SOP/BA-BE/106/2025 Supersedes SOP/BA-BE/106/2022 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 procedure for the…
Read More “BA-BE Studies: SOP for Managing Female Volunteers in BA/BE Trials – V 2.0” »
BA-BE Studies: SOP for Volunteer Identification and Screening Logs – V 2.0 Standard Operating Procedure for Volunteer Identification and Screening Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/105/2025 Supersedes SOP/BA-BE/105/2022 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 proper…
Read More “BA-BE Studies: SOP for Volunteer Identification and Screening Logs – V 2.0” »
BA-BE Studies: SOP for Maintaining Privacy and Confidentiality of Volunteers – V 2.0 Standard Operating Procedure for Maintaining Privacy and Confidentiality of Volunteers in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/104/2025 Supersedes SOP/BA-BE/104/2022 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…
Read More “BA-BE Studies: SOP for Maintaining Privacy and Confidentiality of Volunteers – V 2.0” »
BA-BE Studies: SOP for Emergency Exit and Fire Drill Plan at Clinical Site – V 2.0 Standard Operating Procedure for Emergency Exit and Fire Drill Plan at Clinical Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/103/2025 Supersedes SOP/BA-BE/103/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026…
Read More “BA-BE Studies: SOP for Emergency Exit and Fire Drill Plan at Clinical Site – V 2.0” »
BA-BE Studies: SOP for Contingency Plan for Power or Equipment Failure – V 2.0 Standard Operating Procedure for Contingency Plan for Power or Equipment Failure in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/102/2025 Supersedes SOP/BA-BE/102/2022 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…
Read More “BA-BE Studies: SOP for Contingency Plan for Power or Equipment Failure – V 2.0” »