SOP Guide for Pharma

BA-BE Studies: SOP for Clinical Trial Material Storage at Site – V 2.0

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BA-BE Studies: SOP for Clinical Trial Material Storage at Site – V 2.0

Standard Operating Procedure for Storage of Clinical Trial Material at Site in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/144/2025
Supersedes SOP/BA-BE/144/2022
Page No. Page 1 of 11
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish a standardized procedure for receiving, storing, monitoring, and documenting clinical trial materials (CTM) including investigational medicinal products (IMP), reference products, and ancillary materials at the BA/BE site in compliance with GCP and regulatory requirements.

2. Scope

This SOP is applicable to all clinical research staff involved in the handling and storage of CTM used in

bioavailability and bioequivalence studies conducted at the clinical research facility.

3. Responsibilities

  • Study Pharmacist: Responsible for receipt, storage, labeling, segregation, and documentation of CTM.
  • Clinical Trial Coordinator: Coordinates with the pharmacist and QA to ensure CTM accountability.
  • Quality Assurance (QA): Periodically audits the storage conditions, logs, and access control systems.
  • Principal Investigator (PI): Reviews CTM records and ensures compliance with study protocols.

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4. Accountability

The Clinical Operations Manager is accountable for ensuring CTM storage conditions are maintained as per product specifications and that all personnel involved are trained in this SOP.

5. Procedure

5.1 Receipt of Clinical Trial Material

  1. CTM shall be received only by the designated pharmacist or designee trained in GCP and CTM handling.
  2. Upon receipt:
    • Check CTM carton for integrity and seal conditions.
    • Verify quantity against shipping documents and invoice.
    • Record receipt in Annexure-1: CTM Receipt Log.
    • Ensure presence of Certificate of Analysis (CoA), temperature excursion logs, and invoice.

5.2 Storage Area Conditions

  1. Ensure CTM is stored in designated storage areas:
    • Room Temperature (15–25°C)
    • Refrigerated (2–8°C)
    • Freezer (-20°C or -70°C as applicable)
  2. Monitor and record environmental conditions using calibrated devices with alarms.
  3. CTM storage rooms must be access-controlled and restricted to authorized personnel only.

5.3 Labeling and Segregation

  1. Label all CTM containers with:
    • Study code
    • Batch/lot number
    • Storage condition
    • Expiry date
    • Status (Quarantined, Released, Expired, or Returned)
  2. Segregate CTM by status using:
    • Color-coded bins or labels
    • Physical separation with signage

5.4 Monitoring and Documentation

  1. Record twice-daily temperature and humidity in Annexure-2: CTM Temperature Log.
  2. Any deviation from recommended conditions must be:
    • Reported immediately to the QA team
    • Documented in Annexure-3: Excursion Log
    • Assessed for impact on product quality
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5.5 Expiry Tracking and Disposal

  1. Maintain a tracking sheet for all CTM expiry dates (Annexure-4: CTM Expiry Tracker).
  2. Remove expired or damaged CTM immediately and store in a separate “To Be Destroyed” area.
  3. Destruction must follow SOP/BA-BE/82/2025 and be documented with sponsor approval.

5.6 Periodic Review and Reconciliation

  1. Conduct monthly reconciliation of CTM stock versus dispensing logs.
  2. Document reconciliation outcomes in Annexure-5: CTM Reconciliation Log.
  3. In case of discrepancies, initiate CAPA and report to the PI and sponsor.

5.7 Access Control and Security

  1. Restrict CTM room entry to authorized personnel using:
    • Biometric or access card systems
    • Manual entry logs (Annexure-6: CTM Access Log)
  2. Ensure 24×7 surveillance (CCTV) and alarm systems for temperature excursion alerts.

6. Abbreviations

  • CTM: Clinical Trial Material
  • IMP: Investigational Medicinal Product
  • PI: Principal Investigator
  • QA: Quality Assurance
  • CoA: Certificate of Analysis

7. Documents

  1. CTM Receipt Log – Annexure-1
  2. CTM Temperature Log – Annexure-2
  3. Excursion Log – Annexure-3
  4. CTM Expiry Tracker – Annexure-4
  5. CTM Reconciliation Log – Annexure-5
  6. CTM Access Log – Annexure-6

8. References

  • ICH E6(R2) – Good Clinical Practice
  • Schedule Y – Drugs and Cosmetics Rules, India
  • WHO Guidance on IMP Storage
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CTM Receipt Log

Date CTM Name Batch No. Qty Received Received By Remarks
15/04/2025 Test Product A TP-031 1000 units Sunita Reddy CoA attached

Annexure-2: CTM Temperature Log

Date Time Storage Type Temperature (°C) Recorded By
16/04/2025 09:00 Room Temp 24.2 Rajesh Kumar

Annexure-3: Excursion Log

Date Temperature (°C) Duration Cause Action Taken
16/04/2025 27.5 1 hour Power failure Transferred to backup refrigerator

Annexure-4: CTM Expiry Tracker

CTM Name Batch No. Expiry Date Status
Ref Product B RP-047 30/06/2025 Valid

Annexure-5: CTM Reconciliation Log

CTM Name Qty Received Qty Dispensed Balance Verified By
IMP X 800 640 160 QA Officer

Annexure-6: CTM Access Log

Date Name Time In Time Out Purpose
16/04/2025 Sunita Reddy 10:00 10:30 IMP transfer

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial release New SOP QA Head
17/04/2025 2.0 Expanded procedure and temperature log annexures Audit preparation QA Head
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