SOP for Storage of Non-Pharmacopoeial Grade Raw Materials – V 2.0

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SOP for Storage of Non-Pharmacopoeial Grade Raw Materials – V 2.0

Standard Operating Procedure for Storage of Non-Pharmacopoeial Grade Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/125/2025
Supersedes SOP/RM/125/2022
Page No. Page 1 of 15
Issue Date 23/02/2025
Effective Date 27/02/2025
Review Date 23/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the proper storage of non-pharmacopoeial grade raw materials to ensure material integrity, prevent contamination, and maintain compliance with regulatory requirements.

2. Scope

This SOP applies to all non-pharmacopoeial grade raw materials, including industrial-grade solvents, chemicals, and excipients, stored in the warehouse.

3. Responsibilities

  • Warehouse Personnel: Ensure correct storage, labeling, and segregation of non-pharmacopoeial grade raw materials.
  • Warehouse Manager: Oversee storage operations and ensure compliance with this SOP.
  • Quality Assurance (QA): Conduct inspections and audits to verify compliance with storage requirements.

4. Accountability

The Warehouse Manager is accountable for the implementation of proper storage procedures, while the QA Manager ensures compliance with regulatory and quality standards.

5. Procedure

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5.1 Identification and Classification

  1. Material Identification:
    • Identify raw materials that are non-pharmacopoeial grade at the time of receipt.
    • Classify materials based on their intended use (e.g., industrial solvents, laboratory reagents).
    • Record identified materials in the Non-Pharmacopoeial Material Register (Annexure-1).
  2. Labeling Requirements:
    • Ensure all non-pharmacopoeial materials are labeled clearly with “NON-PHARMACOPOEIAL GRADE” tags.
    • Include material name, batch number, expiry date, and storage conditions on the label.
    • Document label verification in the Label Compliance Log (Annexure-2).

5.2 Storage Conditions

  1. Segregated Storage:
    • Store non-pharmacopoeial grade raw materials separately from pharmacopoeial grade materials to prevent cross-contamination.
    • Use dedicated storage racks or designated storage areas with clear signage.
    • Record storage locations in the Storage Location Log (Annexure-3).
  2. Environmental Control:
    • Maintain storage conditions as specified by the manufacturer (e.g., temperature, humidity).
    • Monitor environmental conditions daily and document in the Environmental Monitoring Log (Annexure-4).

5.3 Handling and Usage

  1. Material Handling:
    • Use appropriate Personal Protective Equipment (PPE) when handling non-pharmacopoeial grade raw materials.
    • Ensure handling equipment is clean and suitable for use with these materials.
    • Document handling procedures in the Material Handling Log (Annexure-5).
  2. Material Issuance:
    • Verify that the material is within its expiry date before issuance.
    • Record material issuance in the Material Issuance Log (Annexure-6).
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5.4 Monitoring and Audits

  1. Daily Monitoring:
    • Warehouse personnel must check the condition of stored materials daily for signs of contamination or degradation.
    • Document observations in the Daily Monitoring Log (Annexure-7).
  2. QA Audits:
    • QA will conduct monthly audits of storage areas to ensure compliance with this SOP.
    • Record audit findings in the QA Audit Log (Annexure-8).

5.5 Handling Deviations and Corrective Actions

  1. Deviation Reporting:
    • Identify deviations such as incorrect labeling, improper storage, or contamination risks.
    • Report deviations immediately to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-9).
  2. Corrective Actions:
    • Investigate the cause of deviations and implement corrective actions such as relabeling or retraining staff.
    • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Non-Pharmacopoeial Material Register (Annexure-1)
  2. Label Compliance Log (Annexure-2)
  3. Storage Location Log (Annexure-3)
  4. Environmental Monitoring Log (Annexure-4)
  5. Material Handling Log (Annexure-5)
  6. Material Issuance Log (Annexure-6)
  7. Daily Monitoring Log (Annexure-7)
  8. QA Audit Log (Annexure-8)
  9. Deviation Log (Annexure-9)
  10. Corrective Action Log (Annexure-10)
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8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO GMP Guidelines
  • OSHA Material Handling and Storage Standards

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Non-Pharmacopoeial Material Register

Date Material Name Batch Number Expiry Date Storage Condition
23/02/2025 Industrial Solvent A Batch 101 23/02/2026 Room Temperature

Annexure-2: Label Compliance Log

Date Material Name Label Verified By Remarks
23/02/2025 Industrial Solvent A Ravi Kumar Label Verified and Correct

Annexure-3: Storage Location Log

Date Material Name Storage Area Placed By
23/02/2025 Industrial Solvent A Non-Pharma Section, Shelf 1 Sunita Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
23/02/2025 2.0 Updated Storage Procedures Regulatory Compliance QA Head
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,