SOP Guide for Pharma

BA-BE Studies: SOP for Logging Receipt of Samples from Clinical Site – V 2.0

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BA-BE Studies: SOP for Logging Receipt of Samples from Clinical Site – V 2.0

Standard Operating Procedure for Logging Receipt of Samples from Clinical Site in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/193/2025
Supersedes SOP/BA-BE/193/2022
Page No. Page 1 of 8
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish a standardized procedure for receiving, inspecting, and logging biological samples such as plasma or serum received from the clinical site to the bioanalytical laboratory in bioavailability/bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to all biological sample shipments from the clinical unit to the bioanalytical facility for analysis during BA/BE studies conducted at [Organization Name].

3. Responsibilities

  • Sample Custodian: Receives, verifies, and logs samples upon arrival.
  • Courier Personnel: Delivers samples and provides signed transport documents.
  • Bioanalytical QA: Verifies chain-of-custody and compliance with transport conditions.
  • Bioanalytical Head: Ensures procedures are followed and discrepancies resolved.
See also  BA-BE Studies: SOP for Preparation and Use of Calibration Standards - V 2.0

4. Accountability

The Bioanalytical Department Head is accountable for ensuring that the receipt and documentation of clinical samples meet GCP and GLP requirements, and that sample integrity is maintained.

5. Procedure

5.1 Pre-Arrival Notification

  1. Clinical site staff informs the receiving lab at least 2 hours before sample shipment.
  2. Details to be shared:
    • Study Code
    • No. of Samples
    • Shipment Date & Time
    • Courier Name & Tracking
  3. Receiving team ensures freezer space and staff readiness.

5.2 Receipt of Samples

  1. Upon arrival:
    • Check external condition of container (no leakage, breakage, tampering).
    • Record ambient temperature if temperature logger is provided.
  2. Accept the consignment only if:
    • Seal is intact
    • Temperature maintained as per requirement (e.g., ≤ −20°C)
  3. Sign off the Sample Transfer Form provided by courier (Annexure-1).

5.3 Verification of Sample Details

  1. Open container in designated receiving area using PPE.
  2. Cross-check sample labels with the Sample Inventory Sheet provided by the clinical site.
  3. Verify:
    • Subject ID
    • Time point
    • Number of vials
    • Sample condition (intact label, no leakage/frosting)
  4. Document discrepancies in Annexure-2: Sample Receipt and Verification Log.
See also  BA-BE Studies: SOP for Reproducibility Assessment Across Runs - V 2.0

5.4 Logging and Storage

  1. Assign a Sample Receipt Log ID to the consignment.
  2. Record all sample details in the Sample Receipt Log Book (Annexure-3).
  3. Transfer samples to appropriate freezer (−20°C or −70°C).
  4. Label storage rack with:
    • Study Code
    • Receipt Date
    • Freezer Number

5.5 Reporting and Resolution

  1. Notify clinical site and QA of:
    • Missing samples
    • Unlabeled/partially labeled vials
    • Improper temperature on arrival
  2. Complete a Sample Receipt Deviation Form if any issues are found (Annexure-4).
  3. All forms and logs must be signed and archived in the Study Master File (SMF).

6. Abbreviations

  • BA/BE: Bioavailability/Bioequivalence
  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • SMF: Study Master File

7. Documents

  1. Sample Transfer Form – Annexure-1
  2. Sample Receipt and Verification Log – Annexure-2
  3. Sample Receipt Log Book – Annexure-3
  4. Sample Receipt Deviation Form – Annexure-4

8. References

  • ICH GCP E6(R2)
  • US FDA Bioanalytical Method Validation Guidance (2022)
  • GLP Guidelines – OECD 14
See also  BA-BE Studies: SOP for Environmental Monitoring in Volunteer Areas - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Transfer Form

Study Code BE/XYZ/2025/07
Date of Shipment 16/04/2025
No. of Samples 320
Courier SafeTemp Logistics
Shipped By Dr. Sunita Reddy

Annexure-2: Sample Receipt and Verification Log

Subject ID Time Point Vial Count Condition Remarks
SUB001 0 hr 2 Good —

Annexure-3: Sample Receipt Log Book

Log ID Date Study Code No. of Samples Freezer
LOG/193/25 17/04/2025 BE/XYZ/2025/07 320 FZ-04

Annexure-4: Sample Receipt Deviation Form

Date 17/04/2025
Deviation One sample missing (SUB015, 4hr point)
Investigated By QA Officer
Action Taken Clinical site informed, CAPA initiated

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Issue New SOP QA Head
17/04/2025 2.0 Expanded logs and deviation documentation Audit Compliance QA Head
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