SOP for Chain of Custody Documentation for Sampled Quarantine Materials – V 2.0

Posted on By

SOP for Chain of Custody Documentation for Sampled Quarantine Materials – V 2.0

Standard Operating Procedure for Chain of Custody Documentation for Sampled Quarantine Materials

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/085/2025
Supersedes SOP/RM/085/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for maintaining accurate and secure Chain of Custody (CoC) documentation for raw materials sampled in the quarantine area. The purpose is to ensure traceability, integrity, and accountability of samples throughout their lifecycle.

2. Scope

This SOP applies to all raw material samples collected in the quarantine area that require testing in the Quality Control (QC) laboratory. It includes procedures for documenting the handling, transfer, and storage of these samples to ensure regulatory compliance.

3. Responsibilities

  • Warehouse Personnel: Ensure proper documentation of samples collected and handed over for testing.
  • Quality Control (QC) Personnel: Verify receipt of samples and maintain chain of custody records during testing and storage.
  • Quality Assurance (QA): Review chain of custody documentation and ensure compliance with regulatory requirements.

4. Accountability

The QC Manager is responsible for ensuring accurate chain of custody documentation and traceability of all samples.

The QA Manager oversees compliance with SOP and regulatory standards.

5. Procedure

5.1 Chain of Custody Principles

  1. Definition:
    • Chain of Custody (CoC) refers to the documented and unbroken transfer of samples from the point of collection to final disposition (testing, storage, or disposal).
  2. Key Requirements:
    • All sample transfers must be documented with dates, times, names, and signatures of personnel involved.
    • Samples must be properly labeled, secured, and stored to prevent tampering or contamination.
See also  SOP for Accepting and Handling of Herbal Raw Materials - V 2.0

5.2 Sample Collection and Initial Documentation

  1. Labeling of Samples:
    • Immediately after collection, label samples with:
      • Material Name
      • Batch/Lot Number
      • Sampled By (Name and Signature)
      • Date and Time of Sampling
      • Storage Conditions (if applicable)
  2. Documentation in Sampling Log:
    • Record all sampling details in the Quarantine Sampling Log (Annexure-1).

5.3 Handover of Samples to QC

  1. Handover Documentation:
    • Complete a Chain of Custody Transfer Form (Annexure-2) detailing:
      • Date and Time of Transfer
      • Name of Person Transferring the Sample (Warehouse Personnel)
      • Name of Person Receiving the Sample (QC Personnel)
      • Signatures of both personnel involved in the transfer
  2. Sample Verification:
    • QC personnel must verify the integrity of the sample and confirm the details on the label before signing the Chain of Custody Transfer Form.
    • Record receipt in the QC Sample Receipt Log (Annexure-3).

5.4 Sample Handling and Storage in QC

  1. Secure Storage:
    • Store samples in designated, access-controlled storage areas within the QC lab.
    • Ensure samples are stored under required conditions (temperature, humidity, etc.).
    • Document storage details in the QC Sample Storage Log (Annexure-4).
  2. Sample Usage and Tracking:
    • Each time a sample is accessed for testing, document the date, time, and personnel involved in the QC Sample Usage Log (Annexure-5).
    • Ensure samples are returned to storage immediately after use.

5.5 Final Disposition of Samples

  1. Post-Testing Storage:
    • Upon completion of testing, retain samples as per regulatory requirements (e.g., for stability studies or re-analysis).
    • Document the final storage or disposal of samples in the Sample Disposition Log (Annexure-6).
  2. Sample Disposal:
    • Dispose of samples following the organization’s waste management procedures.
    • Document disposal details in the Disposal Record (Annexure-7).

5.6 Handling Deviations in Chain of Custody

  1. Deviation Reporting:
    • Document any discrepancies (e.g., missing signatures, lost samples) in the Chain of Custody Deviation Report (Annexure-8).
    • Report deviations to the QA Manager immediately.
  2. Corrective Actions:
    • Investigate the root cause of deviations and implement corrective actions.
    • Document corrective measures in the Corrective Action Log (Annexure-9).
See also  SOP for Receiving of Raw Materials from Vendors - V 2.0

5.7 Training and Compliance

  1. Personnel Training:
    • All personnel involved in sample handling must be trained on chain of custody procedures.
    • Document training in the Training Log (Annexure-10).
  2. Compliance Monitoring:
    • QA must conduct regular audits to ensure adherence to chain of custody protocols.
    • Document audit findings in the Compliance Audit Log (Annexure-11).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • CoC: Chain of Custody

7. Documents

  1. Quarantine Sampling Log (Annexure-1)
  2. Chain of Custody Transfer Form (Annexure-2)
  3. QC Sample Receipt Log (Annexure-3)
  4. QC Sample Storage Log (Annexure-4)
  5. QC Sample Usage Log (Annexure-5)
  6. Sample Disposition Log (Annexure-6)
  7. Disposal Record (Annexure-7)
  8. Chain of Custody Deviation Report (Annexure-8)
  9. Corrective Action Log (Annexure-9)
  10. Training Log (Annexure-10)
  11. Compliance Audit Log (Annexure-11)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • ISO 17025 – General Requirements for the Competence of Testing and Calibration Laboratories

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Quarantine Sampling Log

Date Material Name Batch Number Sampled By Signature
01/02/2025 API-X API-X-2025-001 Ravi Kumar

Annexure-2: Chain of Custody Transfer Form

Date Material Name Batch Number Transferred By Received By Signatures
01/02/2025 API-X API-X-2025-001 Ravi Kumar Sunita Sharma
See also  SOP for Handling and Movement of Quarantined Hazardous Raw Materials - V 2.0

Annexure-3: QC Sample Receipt Log

Date Material Name Batch Number Received By Signature
01/02/2025 API-X API-X-2025-001 Sunita Sharma

Annexure-4: QC Sample Storage Log

Date Material Name Batch Number Storage Location Stored By
01/02/2025 API-X API-X-2025-001 QC Lab – Shelf A1 Ajay Singh

Annexure-5: QC Sample Usage Log

Date Material Name Batch Number Used By Purpose of Use
02/02/2025 API-X API-X-2025-001 Sunita Sharma Initial QC Testing

Annexure-6: Sample Disposition Log

Date Material Name Batch Number Final Disposition Disposed By
05/02/2025 API-X API-X-2025-001 Returned to Storage Ajay Singh

Annexure-7: Disposal Record

Date Material Name Batch Number Disposed By Disposal Method
10/02/2025 API-X API-X-2025-001 Ajay Singh Incineration

Annexure-8: Chain of Custody Deviation Report

Date Material Name Batch Number Deviation Description Reported By
02/02/2025 API-X API-X-2025-001 Missing Signature on Transfer Form Ravi Kumar

Annexure-9: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
03/02/2025 Missing Signature on Transfer Form Updated SOP for Double Verification Ajay Singh Anjali Mehta

Annexure-10: Training Log

Date Training Topic Trainer Attendee Name Signature
04/02/2025 Chain of Custody Documentation QA Manager Sunita Sharma

Annexure-11: Compliance Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
05/02/2025 Chain of Custody Compliance Incomplete Transfer Form Revised Documentation Procedures Anjali Mehta

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated Chain of Custody Procedures Regulatory Compliance QA Head
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,