SOP for Inventory Control of Raw Materials in Quarantine – V 2.0

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SOP for Inventory Control of Raw Materials in Quarantine – V 2.0

Standard Operating Procedure for Inventory Control of Raw Materials in Quarantine

Department Warehouse / Quality Assurance / Inventory Management
SOP No. SOP/RM/069/2025
Supersedes SOP/RM/069/2022
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 inventory control of raw materials stored in the quarantine area to ensure accurate tracking, prevent mix-ups, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, that are stored in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

  • Warehouse Personnel: Maintain accurate inventory records, update material status, and ensure proper labeling.
  • Quality Assurance (QA): Verify inventory accuracy and ensure compliance with GMP and regulatory standards.
  • Inventory Control Team: Perform routine audits and reconcile inventory discrepancies.

4. Accountability

The Warehouse Manager is responsible for maintaining accurate inventory records of quarantined raw materials. The QA Manager ensures compliance with GMP and regulatory guidelines, while the Inventory Control Team performs audits and reconciliations.

5. Procedure

5.1 Receiving and Logging of Raw Materials

  1. Material Receipt:

    • Upon receipt, raw materials must be logged into the Quarantine Inventory System with details including:
      • Material Name
      • Batch/Lot Number
      • Supplier Name
      • Goods Receipt Note (GRN) Number
      • Date of Receipt
    • Assign a unique Quarantine ID to each material and record in the Quarantine Inventory Log (Annexure-1).
  2. Labeling:

    • Label each material with its Quarantine ID, batch number, and status (‘Under Test’).
    • Ensure labels are clear, legible, and securely attached to each container.
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5.2 Inventory Management and Tracking

  1. Inventory Updates:

    • Update inventory records after each of the following activities:
      • Sampling
      • QC Testing
      • Material movement within the quarantine area
      • Release or rejection of materials
    • Record updates in the Inventory Movement Log (Annexure-2).
  2. Status Changes:

    • Change the status of materials from ‘Under Test’ to either ‘Approved’ or ‘Rejected’ after QC testing and QA review.
    • Ensure status updates are reflected in both physical labels and digital inventory records.

5.3 Routine Inventory Audits

  1. Audit Schedule:

    • Conduct routine inventory audits monthly to verify accuracy between physical stock and digital records.
    • Document audit results in the Inventory Audit Log (Annexure-3).
  2. Discrepancy Resolution:

    • Investigate any discrepancies identified during audits and document findings in the Inventory Discrepancy Report (Annexure-4).
    • Implement corrective actions and update records accordingly.

5.4 Material Release and Disposal

  1. Material Release:

    • Upon QA approval, update the status of materials to ‘Released’ and move them to the designated storage area.
    • Document release activities in the Material Release Log (Annexure-5).
  2. Rejected Material Disposal:

    • Move rejected materials to the disposal area and update their status to ‘Rejected’ in the inventory system.
    • Record disposal activities in the Rejected Material Disposal Log (Annexure-6).
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5.5 Handling Inventory Deviations

  1. Deviation Identification:

    • Identify any deviations from inventory procedures, such as incorrect labeling, missing entries, or discrepancies between physical and digital records.
    • Document deviations in the Inventory Deviation Report (Annexure-7).
  2. Corrective Actions:

    • Investigate the cause of deviations and implement corrective actions to prevent recurrence.
    • Record corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • GRN: Goods Receipt Note

7. Documents

  1. Quarantine Inventory Log (Annexure-1)
  2. Inventory Movement Log (Annexure-2)
  3. Inventory Audit Log (Annexure-3)
  4. Inventory Discrepancy Report (Annexure-4)
  5. Material Release Log (Annexure-5)
  6. Rejected Material Disposal Log (Annexure-6)
  7. Inventory Deviation Report (Annexure-7)
  8. Corrective Action Log (Annexure-8)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)

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 Inventory Log

Date Material Name Batch Number Supplier GRN Number Quarantine ID Status
01/02/2025 API-X X-2025-001 Supplier A GRN-12345 QRM-001 Under Test
01/02/2025 Excipient-Y Y-2025-002 Supplier B GRN-12346 QRM-002 Under Test
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Annexure-2: Inventory Movement Log

Date Quarantine ID Movement Description Moved By Verified By (QA)
02/02/2025 QRM-001 Moved to Sampling Area Ravi Kumar Anjali Mehta

Annexure-3: Inventory Audit Log

Date Audited By Discrepancies Found Corrective Action Taken Verified By (QA)
03/02/2025 Sunita Sharma No Discrepancies N/A Ajay Singh

Annexure-4: Inventory Discrepancy Report

Date Quarantine ID Discrepancy Description Reported By Corrective Action Taken
04/02/2025 QRM-002 Missing Label Ravi Kumar Label Replaced and Verified

Annexure-5: Material Release Log

Date Quarantine ID Material Name Batch Number Released By (QA)
05/02/2025 QRM-001 API-X X-2025-001 Anjali Mehta

Annexure-6: Rejected Material Disposal Log

Date Quarantine ID Material Name Batch Number Disposed By Verified By (QA)
05/02/2025 QRM-002 Excipient-Y Y-2025-002 Ajay Singh Anjali Mehta

Annexure-7: Inventory Deviation Report

Date Deviation Description Reported By Corrective Action Taken Verified By (QA)
06/02/2025 Incorrect Status Update Sunita Sharma Status Corrected in Inventory System Ajay Singh

Annexure-8: Corrective Action Log

Date Issue Corrective Action Responsible Person Follow-Up Required
06/02/2025 Missing Label on Excipient-Y Replaced Label and Conducted Staff Training Ravi Kumar Yes

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 Inventory Management Procedures and Documentation Formats Regulatory Compliance QA Head
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