BA-BE Studies: SOP for Documentation of Sample Storage Conditions – V 2.0

Standard Operating Procedure for Documentation of Sample Storage Conditions in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/194/2025
Supersedes	SOP/BA-BE/194/2022
Page No.	Page 1 of 8
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for documenting and maintaining the storage conditions of biological samples such as plasma, serum, and urine during BA/BE studies to ensure sample integrity and compliance with regulatory requirements.

2. Scope

This SOP applies to all biological samples stored in freezers or refrigerators at the bioanalytical facility throughout the duration of BA/BE studies.

3. Responsibilities

Sample Custodian: Ensures sample storage

conditions are monitored and documented.

QA Personnel: Reviews storage logs and validates compliance during internal audits.

Lab Technicians: Monitor temperatures and notify for excursions.

Bioanalytical Head: Ensures SOP adherence and CAPA implementation when required.

4. Accountability

The Head of the Bioanalytical Department is accountable for maintaining compliant and auditable records of sample storage conditions for all biological samples.

5. Procedure

5.1 Designated Storage Areas

Samples are stored in designated:
- Deep freezers (-70°C or lower)
- Freezers (-20°C)
- Refrigerators (2–8°C)
Each unit must have a unique identifier (e.g., FZ-001, RF-002).

5.2 Temperature Monitoring Devices

Equip each unit with a calibrated temperature data logger or digital thermometer.
Devices must be:
- Calibrated annually
- Placed at the center or most critical zone
Attach display readers outside for quick visual check.

5.3 Documentation of Temperature

Record temperatures twice daily (start and end of shift) in Annexure-1: Sample Storage Temperature Log.
Entries must include:
- Date and time
- Storage unit ID
- Temperature (°C)
- Initials of personnel
Print and archive logger graphs weekly in a binder specific to each unit.

5.4 Handling Temperature Excursions

If temperature is out of acceptable range:
- Label the storage unit as “Under Observation.”
- Move samples to backup storage.
- Document excursion in Annexure-2: Temperature Excursion Log.
- Inform QA immediately.
Initiate CAPA as needed and document resolution.

5.5 Backup Power and Alarm Systems

Ensure:
- Uninterrupted Power Supply (UPS) or generator support is available.
- Freezer units are connected to temperature alarms with 24×7 alert notification.

5.6 Sample Inventory Mapping

Each freezer must maintain an updated Sample Inventory Sheet (Annexure-3).
Include:
- Study code
- Rack and box number
- Sample IDs and date of placement
Reconcile inventory monthly with receipt logs.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
UPS: Uninterrupted Power Supply
CAPA: Corrective and Preventive Action
°C: Degrees Celsius

7. Documents

Sample Storage Temperature Log – Annexure-1
Temperature Excursion Log – Annexure-2
Sample Inventory Sheet – Annexure-3

8. References

ICH GCP E6(R2)
OECD GLP Principles
21 CFR Part 58 – FDA GLP Regulations

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 Storage Temperature Log

Date	Time	Unit ID	Temperature (°C)	Initials
17/04/2025	09:00	FZ-003	-22.3	AV

Annexure-2: Temperature Excursion Log

Date	Unit ID	Observed Temp (°C)	Duration	Corrective Action
16/04/2025	FZ-002	-14.2	1 hour	Transferred to FZ-001

Annexure-3: Sample Inventory Sheet

Study Code	Rack No.	Box No.	Sample IDs	Date Placed
BE/XYZ/2025/05	Rack-2	Box-3	SUB001 to SUB010	12/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New Procedure	QA Head
17/04/2025	2.0	Included digital logging and excursion protocol	Audit Enhancement	QA Head