SOP Guide for Pharma

SOP for Managing Retained Samples of Quarantined Raw Materials – V 2.0

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SOP for Managing Retained Samples of Quarantined Raw Materials – V 2.0

Standard Operating Procedure for Managing Retained Samples of Quarantined Raw Materials

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/079/2025
Supersedes SOP/RM/079/2022
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 guidelines for the proper management of retained samples of quarantined raw materials. It ensures that retained samples are stored, monitored, and maintained according to Good Manufacturing Practices (GMP) to support future investigations, regulatory audits, and quality checks.

2. Scope

This SOP applies to all retained samples of raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials received and stored in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

  • Quality Control (QC) Personnel: Collect, label, and store retained samples appropriately and maintain complete records.
  • Warehouse Personnel: Assist in the retrieval and secure storage of retained samples in designated areas.
  • Quality Assurance (QA): Ensure compliance with retention policies, oversee periodic audits, and approve disposal of expired retained samples.

4. Accountability

The QC Manager is responsible for ensuring the correct handling and documentation of retained

samples. The QA Manager ensures compliance with retention requirements and approves any deviations or disposals.

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5. Procedure

5.1 Collection of Retained Samples

  1. Sampling Process:
    • Retain an additional sample of each batch of raw materials during the initial sampling process.
    • The retained sample quantity should be sufficient for complete re-analysis, typically:
      • Solids: 100g to 500g, depending on the material.
      • Liquids: 250ml to 500ml, depending on the testing requirements.
  2. Labeling Retained Samples:
    • Clearly label retained samples with the following details:
      • Material Name
      • Batch/Lot Number
      • Date of Sampling
      • Sampled By (Name & Signature)
      • Retention Period
    • Ensure labels are secure, legible, and resistant to environmental conditions.

5.2 Storage of Retained Samples

  1. Storage Conditions:
    • Store retained samples in designated areas within the QC laboratory or secure storage rooms.
    • Maintain storage conditions as per the material’s specifications (e.g., temperature, humidity).
    • For temperature-sensitive materials, store in controlled environments like cold rooms or refrigerators.
  2. Storage Documentation:
    • Document the storage location and conditions in the Retained Sample Storage Log (Annexure-1).
    • Ensure samples are organized systematically to facilitate easy retrieval.

5.3 Monitoring and Periodic Review

  1. Routine Inspections:
    • Perform monthly inspections of retained samples to check for:
      • Label integrity
      • Container condition (no leakage or damage)
      • Compliance with storage conditions
    • Record inspection results in the Retained Sample Inspection Log (Annexure-2).
  2. Stability Monitoring:
    • For materials requiring stability monitoring, conduct periodic testing based on stability protocols.
    • Document test results in the Stability Testing Log (Annexure-3).

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5.4 Retention Period and Disposal

  1. Retention Period:
    • Retain samples for at least one year after the expiry of the finished product batch or as per regulatory requirements.
    • For materials not used in production, retain samples for one year from the date of receipt.
  2. Disposal of Retained Samples:
    • Dispose of retained samples after the retention period with QA approval.
    • Document disposal activities in the Retained Sample Disposal Log (Annexure-4).

5.5 Handling Deviations in Retained Sample Management

  1. Deviation Reporting:
    • Report any discrepancies or deviations in retained sample management to the QA Manager.
    • Document deviations in the Retained Sample Deviation Report (Annexure-5).
  2. Corrective Actions:
    • Investigate the cause of the deviation and implement corrective measures.
    • Document corrective actions in the Corrective Action Log (Annexure-6).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Retained Sample Storage Log (Annexure-1)
  2. Retained Sample Inspection Log (Annexure-2)
  3. Stability Testing Log (Annexure-3)
  4. Retained Sample Disposal Log (Annexure-4)
  5. Retained Sample Deviation Report (Annexure-5)
  6. Corrective Action Log (Annexure-6)

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

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10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Retained Sample Storage Log

Date Material Name Batch Number Storage Location Stored By
01/02/2025 API-X X-2025-001 Cold Room A Ravi Kumar

Annexure-2: Retained Sample Inspection Log

Date Material Name Batch Number Inspection Findings Inspected By
05/02/2025 API-X X-2025-001 No Issues Detected Anjali Mehta

Annexure-3: Stability Testing Log

Date Material Name Batch Number Test Performed Results Tested By
10/02/2025 API-X X-2025-001 Moisture Content Within Limits Ajay Singh

Annexure-4: Retained Sample Disposal Log

Date Material Name Batch Number Disposal Method Disposed By Approved By (QA)
01/03/2025 API-X X-2023-001 Incineration Sunita Sharma Anjali Mehta

Annexure-5: Retained Sample Deviation Report

Date Material Name Batch Number Deviation Description Reported By
15/02/2025 API-X X-2025-001 Incorrect Storage Temperature Ravi Kumar

Annexure-6: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
16/02/2025 Incorrect Storage Temperature Calibrated Temperature Control System Ajay Singh 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 Procedures for Managing Retained Samples Regulatory Compliance QA Head
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