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
- 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).
- 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.
5.2 Sample Collection and Initial Documentation
- 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)
- Documentation in Sampling Log:
- Record all sampling details in the Quarantine Sampling Log (Annexure-1).
5.3 Handover of Samples to QC
- 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
- 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
- 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).
- 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
- 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).
- 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
- 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.
- Corrective Actions:
- Investigate the root cause of deviations and implement corrective actions.
- Document corrective measures in the Corrective Action Log (Annexure-9).
5.7 Training and Compliance
- Personnel Training:
- All personnel involved in sample handling must be trained on chain of custody procedures.
- Document training in the Training Log (Annexure-10).
- 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
- Quarantine Sampling Log (Annexure-1)
- Chain of Custody Transfer Form (Annexure-2)
- QC Sample Receipt Log (Annexure-3)
- QC Sample Storage Log (Annexure-4)
- QC Sample Usage Log (Annexure-5)
- Sample Disposition Log (Annexure-6)
- Disposal Record (Annexure-7)
- Chain of Custody Deviation Report (Annexure-8)
- Corrective Action Log (Annexure-9)
- Training Log (Annexure-10)
- 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
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Checked By |
Approved By |
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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 |
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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 |
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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 |
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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 |
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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 |