SOP Guide for Pharma

BA-BE Studies: SOP for Processing and Centrifugation of Blood Samples – V 2.0

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BA-BE Studies: SOP for Processing and Centrifugation of Blood Samples – V 2.0

Standard Operating Procedure for Processing and Centrifugation of Blood Samples in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/072/2025
Supersedes SOP/BA-BE/072/2022
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 standardized method for the timely and consistent processing and centrifugation of blood samples collected during Bioavailability/Bioequivalence (BA/BE) studies to ensure plasma integrity and analytical reliability.

2. Scope

This SOP applies to all personnel involved in handling, processing, and centrifuging blood samples post-collection during clinical phases of BA/BE studies.

3. Responsibilities

See also  BA-BE Studies: SOP for Handling Serious Adverse Events (SAEs) - V 2.0

4. Accountability

The Bioanalytical Lab Manager is accountable for ensuring that the centrifugation process complies with study protocols, equipment calibration requirements, and regulatory standards.

5. Procedure

5.1 Sample Receipt and Handling

  1. Transport collected blood samples to the sample processing area within 30 minutes of collection.
  2. Store samples temporarily at room temperature unless otherwise specified in the protocol.

5.2 Centrifuge Preparation

  1. Ensure centrifuge is:
    • Calibrated and validated
    • Cleaned before and after each batch
    • Balanced with tubes placed opposite each other
  2. Pre-cool the centrifuge if protocol requires temperature-controlled centrifugation.

5.3 Centrifugation Process

  1. Spin blood samples as per protocol-defined parameters:
    • Typically at 4000 rpm for 10 minutes at 4°C
  2. Use timer and log actual start and end times in Annexure-1: Centrifugation Log Sheet.
  3. Ensure that no disturbance or re-mixing of plasma occurs after centrifugation.

5.4 Post-Centrifugation Steps

  1. Carefully transfer the separated plasma into pre-labeled plasma tubes using disposable pipettes.
  2. Label plasma tubes with:
    • Subject ID
    • Time point
    • Period number
    • Aliquot number (if applicable)
  3. Place plasma samples in pre-designated freezer racks at -20°C or -70°C as per protocol.
See also  BA-BE Studies: SOP for Sample Storage at -20°C and -70°C - V 2.0

5.5 Documentation

  1. Record:
    • Sample receipt time
    • Time of centrifugation
    • Operator initials
    • Equipment used and temperature
  2. Document in Annexure-2: Plasma Transfer and Storage Log.

5.6 Deviation Handling

  1. Any centrifugation delay or equipment malfunction must be documented in Annexure-3: Processing Deviation Log.
  2. Inform the QA team and Principal Investigator for impact assessment.

6. Abbreviations

7. Documents

  1. Centrifugation Log Sheet – Annexure-1
  2. Plasma Transfer and Storage Log – Annexure-2
  3. Processing Deviation Log – Annexure-3

8. References

See also  BA-BE Studies: SOP for Protocol and SAP (Statistical Analysis Plan) Integration - 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: Centrifugation Log Sheet

Date Subject ID Start Time End Time RPM Temp Equipment ID Initials
17/04/2025 VOL-072 08:35 08:45 4000 4°C CENT-03 R. Pawar

Annexure-2: Plasma Transfer and Storage Log

Subject ID Time Point Transfer Time Aliquot Label Freezer ID Rack No. Operator
VOL-072 2h 08:50 VOL072-P2-2h FZ-02 R3 Sunita Reddy

Annexure-3: Processing Deviation Log

Subject ID Timepoint Deviation Reason Action Taken QA Review
VOL-072 4h Centrifugation delayed 15 min Power fluctuation Backup centrifuge used Reviewed

Revision History:

Revision Date Revision No. Details Reason Approved By
15/01/2022 1.0 Initial SOP release Process standardization QA Head
17/04/2025 2.0 Added deviation log and equipment ID tracking Audit compliance QA Head
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