SOP for Ensuring Proper Documentation and Traceability in Quarantine Area – V 2.0

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SOP for Ensuring Proper Documentation and Traceability in Quarantine Area – V 2.0

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

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5.1 Documentation Requirements for Quarantined Materials

  1. 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
  2. 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).

5.2 Traceability of Quarantined Materials

  1. 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
  2. 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

  1. 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).
  2. 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

  1. 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.
  2. 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).
See also  SOP for Checking Compliance with Good Distribution Practices (GDP) at Receipt - V 2.0

5.5 Training on Documentation Procedures

  1. 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

  1. Material Receipt Log (Annexure-1)
  2. Quarantine Labeling Log (Annexure-2)
  3. Material Movement Log (Annexure-3)
  4. Sampling Log (Annexure-4)
  5. Testing Results Log (Annexure-5)
  6. Material Release Form (Annexure-6)
  7. Material Release Log (Annexure-7)
  8. Material Rejection Form (Annexure-8)
  9. Material Rejection Log (Annexure-9)
  10. Quarantine Documentation Archive (Annexure-10)
  11. Documentation Review Log (Annexure-11)
  12. 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

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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
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