handling of samples, and documentation.

Clinical Research Coordinator (CRC): Ensures sample transfer timelines are met and deviations are documented.

QA Personnel: Monitors compliance and reviews sample processing logs.

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.

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

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• QA: Quality Assurance
• ID: Identification

7. Documents

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

8. References

• ICH E6(R2) – Good Clinical Practice
• FDA Guidance for Industry on BA/BE Studies
• Study-Specific Protocol and Bioanalytical Plan

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