SOP for Record-Keeping of Raw Materials Held in Quarantine – V 2.0

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SOP for Record-Keeping of Raw Materials Held in Quarantine – V 2.0

Standard Operating Procedure for Record-Keeping of Raw Materials Held in Quarantine

Department Quality Assurance / Warehouse / Quality Control
SOP No. SOP/RM/094/2025
Supersedes SOP/RM/094/2022
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 procedures for accurate and systematic record-keeping of raw materials held in quarantine. It ensures that all materials are properly documented to maintain traceability, compliance with regulatory requirements, and efficient inventory management.

2. Scope

This SOP applies to all raw materials received at the facility, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, that are placed in quarantine pending quality testing and approval.

3. Responsibilities

  • Warehouse Personnel: Accurately log raw material receipt, quarantine placement, and movement in designated records.
  • Quality Control (QC): Record all testing activities related to quarantined materials and communicate results to QA.
  • Quality Assurance (QA): Review and verify all records for accuracy, completeness, and compliance with regulatory standards.

4. Accountability

The QA Manager is accountable for ensuring the accuracy and integrity of quarantine records, while the Warehouse Manager is responsible for maintaining up-to-date and complete documentation of all

quarantined materials.

5. Procedure

5.1 Documentation Requirements for Quarantined Raw Materials

  1. Initial Recording at Receipt:
    • Upon receipt, raw materials must be logged in the Raw Material Receiving Log (Annexure-1).
    • Include the following details:
      • Material Name
      • Batch/Lot Number
      • Supplier Information
      • Date of Receipt
      • Quarantine Location
  2. Labeling of Quarantined Materials:
    • Ensure that all materials are clearly labeled with quarantine status, batch number, and receipt date.
    • Labels must be updated with testing status once results are available.
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5.2 Record-Keeping During Testing and Inspection

  1. Sampling and Testing Records:
    • QC must document all sampling and testing activities in the Quarantine Sampling Log (Annexure-2).
    • Details to be recorded include:
      • Sampling Date
      • Test Performed
      • Testing Personnel
      • Results (Pass/Fail)
  2. Non-Conformance Documentation:
    • Any deviations or non-conformances identified during testing must be recorded in the Non-Conformance Log (Annexure-3).

5.3 Documentation of Material Release or Rejection

  1. Material Release Records:
    • Once materials pass testing, QA must complete the Material Release Authorization Form (Annexure-4).
    • Update the Quarantine Release Log with the release date and approval signature (Annexure-5).
  2. Material Rejection Records:
    • For materials that fail testing, complete the Material Rejection Form (Annexure-6).
    • Document the rejection decision and subsequent movement to the rejection area in the Quarantine Rejection Log (Annexure-7).

5.4 Digital and Manual Record-Keeping Systems

  1. Electronic Records:
    • Where electronic systems are used, ensure compliance with 21 CFR Part 11 requirements for electronic records and signatures.
    • All electronic records must be backed up regularly and access must be restricted to authorized personnel only.
  2. Manual Records:
    • Manual records must be maintained in bound logbooks with sequentially numbered pages.
    • Corrections to manual records should be made by drawing a single line through the error, writing the correction next to it, and initialing with the date.

5.5 Review and Archiving of Quarantine Records

  1. QA Review:
    • QA must periodically review all quarantine records for accuracy, completeness, and compliance with SOPs.
    • Document findings and corrective actions (if any) in the Record Review Log (Annexure-8).
  2. Record Retention and Archiving:
    • All quarantine records must be retained for a minimum of five years or as per regulatory requirements.
    • Archive records securely in the designated record room or electronic document management system (EDMS) and document archiving in the Record Archiving Log (Annexure-9).
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5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All warehouse, QC, and QA personnel involved in record-keeping must be trained in documentation procedures and regulatory compliance.
    • Document training sessions in the Training Log (Annexure-10).
  2. Compliance Audits:
    • QA conducts periodic audits of the record-keeping process to ensure ongoing compliance with SOPs and regulatory requirements.
    • 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
  • EDMS: Electronic Document Management System
  • APIs: Active Pharmaceutical Ingredients

7. Documents

  1. Raw Material Receiving Log (Annexure-1)
  2. Quarantine Sampling Log (Annexure-2)
  3. Non-Conformance Log (Annexure-3)
  4. Material Release Authorization Form (Annexure-4)
  5. Quarantine Release Log (Annexure-5)
  6. Material Rejection Form (Annexure-6)
  7. Quarantine Rejection Log (Annexure-7)
  8. Record Review Log (Annexure-8)
  9. Record Archiving 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
  • 21 CFR Part 11 – Electronic Records; Electronic Signatures
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receiving Log

Date Material Name Batch Number Supplier Quarantine Location Received By
01/02/2025 API-X API-X-2025-001 Supplier A Quarantine Area 1 Ravi Kumar

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Annexure-2: Quarantine Sampling Log

Date Material Name Batch Number Sampled By Test Conducted Result
02/02/2025 API-X API-X-2025-001 Sunita Sharma Purity Test Pass

Annexure-3: Non-Conformance Log

Date Material Name Batch Number Description of Non-Conformance Corrective Action
03/02/2025 API-Y API-Y-2025-002 Failed Moisture Test Re-tested after drying

Annexure-4: Material Release Authorization Form

Date Material Name Batch Number Released By Signature
04/02/2025 API-X API-X-2025-001 Anjali Mehta

Annexure-5: Quarantine Release Log

Date Material Name Batch Number Released To Released By
04/02/2025 API-X API-X-2025-001 Production Anjali Mehta

Annexure-6: 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-7: Quarantine 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-8: Record Review Log

Date Reviewed By Findings Corrective Actions
06/02/2025 Anjali Mehta Minor Data Entry Error Corrected Entry

Annexure-9: Record Archiving Log

Date Document Type Archived By Location
07/02/2025 Quarantine Logs Ravi Kumar Record Room A

Annexure-10: Training Log

Date Training Topic Trainer Attendee Name Signature
08/02/2025 Quarantine Record-Keeping Procedures QA Manager Sunita Sharma

Annexure-11: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
09/02/2025 Record-Keeping Compliance Audit No Major Issues Found N/A 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 Record-Keeping Procedures and Documentation Formats Regulatory Compliance QA Head
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,