SOP for Handling and Storage of Material Samples and Retention Samples – V 2.0

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SOP for Handling and Storage of Material Samples and Retention Samples – V 2.0

Standard Operating Procedure for Handling and Storage of Material Samples and Retention Samples

Department Quality Assurance / Warehouse / QC
SOP No. SOP/RM/151/2025
Supersedes SOP/RM/151/2022
Page No. Page 1 of 12
Issue Date 20/03/2025
Effective Date 27/03/2025
Review Date 20/03/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the guidelines for the proper handling, storage, and documentation of material samples and retention samples to ensure their integrity, traceability, and compliance with regulatory requirements.

2. Scope

This SOP applies to all personnel involved in the sampling, storage, and management of raw material samples and retention samples within the Quality Control (QC) laboratory, warehouse, and Quality Assurance (QA) units.

3. Responsibilities

  • Quality Control (QC) Personnel: Responsible for the collection, labeling, and testing of samples.
  • Warehouse Personnel: Ensure proper storage conditions for retention samples and maintain accurate records.
  • Quality Assurance (QA): Verify sample handling procedures, maintain retention sample records, and conduct periodic audits.
  • Warehouse Manager: Oversee the storage environment, ensure compliance with SOPs, and facilitate audits.

4. Accountability

The Quality Assurance (QA) Manager is accountable for ensuring compliance with the handling and storage procedures for material and retention samples. The Warehouse Manager

is responsible for maintaining appropriate storage conditions.

5. Procedure

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5.1 Collection and Labeling of Samples

  1. Sampling Procedure:
    • QC personnel will collect samples following the approved sampling plan and GMP guidelines.
    • Use sterile, labeled containers for sample collection to prevent contamination.
  2. Labeling Requirements:
    • Each sample must be labeled with the following information:
      • Material Name
      • Batch/Lot Number
      • Sampling Date
      • Sampler’s Name and Signature
      • Storage Conditions
    • Document all labeling in the Sample Collection Log (Annexure-1).

5.2 Storage of Samples

  1. Primary Sample Storage:
    • Store primary samples in the QC lab under controlled conditions (temperature, humidity).
    • Ensure samples are placed in dedicated storage cabinets with restricted access.
    • Document storage locations in the Primary Sample Storage Log (Annexure-2).
  2. Retention Sample Storage:
    • Retention samples should be stored in a designated retention sample room or area in the warehouse.
    • Ensure the storage environment is monitored for temperature, humidity, and other relevant factors.
    • Document retention sample storage in the Retention Sample Log (Annexure-3).

5.3 Handling of Retention Samples

  1. Access Control:
    • Limit access to retention samples to authorized QA and QC personnel only.
    • Maintain an Access Control Log for retention sample storage (Annexure-4).
  2. Sample Withdrawal:
    • When withdrawing retention samples for testing or regulatory purposes, ensure proper documentation in the Sample Withdrawal Log (Annexure-5).
    • Return any unused portions to the retention storage area, ensuring no contamination.

5.4 Periodic Review and Disposal of Samples

  1. Review of Retention Samples:
    • QA will conduct periodic reviews of retention samples to ensure proper storage and documentation.
    • Document reviews in the Retention Sample Review Log (Annexure-6).
  2. Disposal of Expired Samples:
    • Dispose of expired or unused samples following regulatory guidelines and company SOPs.
    • Ensure proper documentation of sample disposal in the Sample Disposal Log (Annexure-7).
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control

7. Documents

  1. Sample Collection Log (Annexure-1)
  2. Primary Sample Storage Log (Annexure-2)
  3. Retention Sample Log (Annexure-3)
  4. Access Control Log (Annexure-4)
  5. Sample Withdrawal Log (Annexure-5)
  6. Retention Sample Review Log (Annexure-6)
  7. Sample Disposal Log (Annexure-7)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
  • ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Sample Collection Log

Date Material Name Batch Number Sampling Location Sampler Name Signature
20/03/2025 Citric Acid CA-5678 Warehouse A1 Ravi Kumar RK
20/03/2025 Sodium Hydroxide NAOH-2345 Warehouse B3 Neha Verma NV

Annexure-2: Primary Sample Storage Log

Date Material Name Batch Number Storage Location Stored By
20/03/2025 Citric Acid CA-5678 QC Lab Shelf 1 Priya Singh
20/03/2025 Sodium Hydroxide NAOH-2345 QC Lab Shelf 3 Amit Joshi
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Annexure-3: Retention Sample Log

Date Material Name Batch Number Storage Location Stored By
20/03/2025 Citric Acid CA-5678 Retention Room Rack A1 Ravi Kumar
20/03/2025 Sodium Hydroxide NAOH-2345 Retention Room Rack B2 Neha Verma

Annexure-4: Access Control Log

Date Employee Name Access Time Reason for Access Authorized By
20/03/2025 Ravi Kumar 10:00 AM Sample storage Priya Singh
20/03/2025 Neha Verma 2:00 PM Sample retrieval for testing Amit Joshi

Annexure-5: Sample Withdrawal Log

Date Material Name Batch Number Quantity Withdrawn Purpose of Withdrawal Withdrawn By
20/03/2025 Citric Acid CA-5678 200 g Stability Testing Ravi Kumar
20/03/2025 Sodium Hydroxide NAOH-2345 150 g Regulatory Submission Neha Verma

Annexure-6: Retention Sample Review Log

Date Material Name Batch Number Condition of Sample Reviewed By
20/03/2025 Citric Acid CA-5678 Good, no issues Priya Singh
20/03/2025 Sodium Hydroxide NAOH-2345 Good, no issues Amit Joshi

Annexure-7: Sample Disposal Log

Date Material Name Batch Number Quantity Disposed Disposal Method Disposed By
20/03/2025 Citric Acid CA-5678 500 g Incineration Ravi Kumar
20/03/2025 Sodium Hydroxide NAOH-2345 300 g Neutralization Neha Verma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
20/03/2025 2.0 Updated sample storage procedures Alignment with revised GMP guidelines QA Head
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