Standard Operating Procedure for Ensuring Proper Documentation and Traceability in Quarantine Area
Department | Quality Assurance / Warehouse |
---|---|
SOP No. | SOP/RM/100/2025 |
Supersedes | SOP/RM/100/2022 |
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 documentation and ensuring complete traceability of raw materials stored in the quarantine area. It ensures compliance with Good Manufacturing Practices (GMP) and regulatory standards, facilitating effective tracking and accountability of all quarantined materials.
2. Scope
This SOP applies to all raw materials received at the facility and stored in the quarantine area, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other materials awaiting quality approval or rejection.
3. Responsibilities
- Warehouse Personnel: Ensure proper labeling, documentation, and storage of quarantined materials. Maintain accurate records of material movement within the quarantine area.
- Quality Assurance (QA): Oversee the accuracy and completeness of documentation related to quarantined materials and ensure traceability from receipt to release or rejection.
- Quality Control (QC): Conduct sampling and testing of quarantined materials and ensure proper documentation of results.
4. Accountability
The QA Manager is accountable for ensuring that
all quarantine documentation is complete, accurate, and compliant with regulatory requirements. The Warehouse Manager is responsible for the traceability and secure storage of materials in the quarantine area.
5. Procedure
5.1 Documentation Requirements for Quarantined Materials
- Material Receipt Documentation:
- Record all incoming materials in the Material Receipt Log (Annexure-1).
- Include the following information:
- Material Name
- Batch Number
- Supplier Name
- Date of Receipt
- Purchase Order (PO) Number
- Quarantine Labeling:
- Label each quarantined material with:
- “QUARANTINE” status
- Material Name and Batch Number
- Date of Receipt and Expiry Date
- Storage Location within the quarantine area
- Document the labeling details in the Quarantine Labeling Log (Annexure-2).
- Label each quarantined material with:
5.2 Traceability of Quarantined Materials
- Material Movement Tracking:
- Record all movements of quarantined materials within the facility in the Material Movement Log (Annexure-3).
- Include movement details such as:
- Date and Time of Movement
- Origin and Destination Locations
- Reason for Movement (e.g., sampling, testing, inspection)
- Personnel Involved
- Sampling and Testing Documentation:
- Document all sampling activities in the Sampling Log (Annexure-4).
- QC must record testing results in the Testing Results Log (Annexure-5), ensuring proper linkage to the respective material batch.
5.3 Release and Rejection Documentation
- Material Release Documentation:
- QA must complete the Material Release Form (Annexure-6) for all materials approved for use.
- Record the release in the Material Release Log (Annexure-7).
- Material Rejection Documentation:
- For materials that fail testing, QA must complete the Material Rejection Form (Annexure-8).
- Document the rejection in the Material Rejection Log (Annexure-9).
5.4 Archiving and Reviewing Documentation
- Document Archiving:
- All quarantine-related documentation must be archived securely in the Quarantine Documentation Archive (Annexure-10).
- Ensure that documents are accessible for regulatory audits and internal reviews.
- Periodic Documentation Review:
- QA will conduct periodic reviews of quarantine documentation to ensure accuracy and completeness.
- Record review findings in the Documentation Review Log (Annexure-11).
5.5 Training on Documentation Procedures
- Personnel Training:
- All personnel involved in quarantine operations must be trained on documentation and traceability requirements.
- Document training activities in the Training Log (Annexure-12).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- PO: Purchase Order
7. Documents
- Material Receipt Log (Annexure-1)
- Quarantine Labeling Log (Annexure-2)
- Material Movement Log (Annexure-3)
- Sampling Log (Annexure-4)
- Testing Results Log (Annexure-5)
- Material Release Form (Annexure-6)
- Material Release Log (Annexure-7)
- Material Rejection Form (Annexure-8)
- Material Rejection Log (Annexure-9)
- Quarantine Documentation Archive (Annexure-10)
- Documentation Review Log (Annexure-11)
- Training Log (Annexure-12)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Material Receipt Log
Date | Material Name | Batch Number | Supplier | Received By |
---|---|---|---|---|
01/02/2025 | API-X | API-X-2025-001 | Supplier A | Ravi Kumar |
Annexure-2: Quarantine Labeling Log
Date | Material Name | Batch Number | Labeled By | Location |
---|---|---|---|---|
01/02/2025 | API-X | API-X-2025-001 | Sunita Sharma | Quarantine Area 1 |
Annexure-3: Material Movement Log
Date | Material Name | Batch Number | Movement Description | Moved By |
---|---|---|---|---|
02/02/2025 | API-X | API-X-2025-001 | Transferred to QC for Sampling | Ravi Kumar |
Annexure-4: Sampling Log
Date | Material Name | Batch Number | Sampled By | Sample Quantity |
---|---|---|---|---|
02/02/2025 | API-X | API-X-2025-001 | Anjali Mehta | 100g |
Annexure-5: Testing Results Log
Date | Material Name | Batch Number | Test Conducted | Result | Tested By |
---|---|---|---|---|---|
03/02/2025 | API-X | API-X-2025-001 | Purity Test | Pass | Sunita Sharma |
Annexure-6: Material Release Form
Date | Material Name | Batch Number | Released By | Signature |
---|---|---|---|---|
04/02/2025 | API-X | API-X-2025-001 | Anjali Mehta |
Annexure-7: Material Release Log
Date | Material Name | Batch Number | Released To | Released By |
---|---|---|---|---|
04/02/2025 | API-X | API-X-2025-001 | Production | Anjali Mehta |
Annexure-8: Material Rejection Form
Date | Material Name | Batch Number | Rejected By | Reason for Rejection |
---|---|---|---|---|
05/02/2025 | API-Y | API-Y-2025-002 | Anjali Mehta | Failed Moisture Test |
Annexure-9: Material Rejection Log
Date | Material Name | Batch Number | Rejection Status | Handled By |
---|---|---|---|---|
05/02/2025 | API-Y | API-Y-2025-002 | Moved to Rejection Area | Ravi Kumar |
Annexure-10: Quarantine Documentation Archive
Date | Document Type | Archived By | Location |
---|---|---|---|
06/02/2025 | Material Logs | Sunita Sharma | Archive Room B |
Annexure-11: Documentation Review Log
Date | Reviewed By | Findings | Corrective Actions |
---|---|---|---|
07/02/2025 | Anjali Mehta | Minor documentation discrepancies found | Corrections implemented by Ravi Kumar |
Annexure-12: Training Log
Date | Training Topic | Trainer | Attendee Name | Signature |
---|---|---|---|---|
08/02/2025 | Proper Documentation and Traceability in Quarantine Area | QA Manager | Ravi Kumar |
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 Documentation Formats and Traceability Procedures | Regulatory Compliance | QA Head |