SOP Guide for Pharma

SOP for Receiving and Storing Raw Materials in Different Packaging Forms – V 2.0

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SOP for Receiving and Storing Raw Materials in Different Packaging Forms – V 2.0

Standard Operating Procedure for Receiving and Storing Raw Materials in Different Packaging Forms

Department Warehouse / Quality Assurance
SOP No. SOP/RM/128/2025
Supersedes SOP/RM/128/2022
Page No. Page 1 of 15
Issue Date 25/02/2025
Effective Date 29/02/2025
Review Date 25/02/2026

1. Purpose

This Standard Operating Procedure (SOP) provides detailed instructions for the proper receiving and storage of raw materials arriving in various packaging forms to ensure material integrity, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials received in drums, bags, carboys, cartons, and other packaging forms at the warehouse.

3. Responsibilities

4. Accountability

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

5. Procedure

5.1 Receiving Raw Materials

  1. Inspection at Receipt:
    • Inspect all raw material consignments upon arrival for visible damage, contamination, or leakage.
    • Verify packaging integrity (e.g., sealed drums, intact bags) and ensure materials match purchase orders.
    • Document findings in the Receiving Inspection Log (Annexure-1).
  2. Verification of Documentation:
    • Check accompanying documents such as the Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and delivery challans.
    • Ensure batch numbers, quantities, and specifications match the received materials.
    • Document verification in the Document Compliance Log (Annexure-2).
See also  SOP for Handling and Storage of Liquid Raw Materials in Bulk Containers - V 2.0

5.2 Handling and Storage Based on Packaging Forms

  1. Storage of Drums:
    • Store drums on pallets to prevent direct contact with the floor and ensure stability to prevent rolling.
    • Keep flammable or hazardous materials in designated areas with proper ventilation and labeling.
    • Document storage details in the Drum Storage Log (Annexure-3).
  2. Storage of Bags:
    • Stack bags neatly on pallets, ensuring they are not overstacked to avoid crushing.
    • Protect bags from moisture by storing them in dry areas or using moisture barriers.
    • Record storage information in the Bag Storage Log (Annexure-4).
  3. Storage of Carboys:
    • Store carboys upright and secure them to prevent tipping or spillage.
    • Label carboys clearly with contents, batch numbers, and handling instructions.
    • Document storage in the Carboy Storage Log (Annexure-5).
  4. Storage of Cartons and Other Forms:
    • Stack cartons on shelves or pallets, ensuring labels are visible for easy identification.
    • Ensure that fragile materials are stored in designated areas with appropriate signage.
    • Record storage details in the General Packaging Storage Log (Annexure-6).
See also  SOP for Verifying Regulatory Compliance for Imported Raw Materials - V 2.0

5.3 Labeling and Segregation

  1. Labeling Requirements:
    • Ensure all packaging forms are labeled with material name, batch number, expiry date, and storage instructions.
    • Use color-coded labels for high-risk or sensitive materials.
    • Document labeling compliance in the Label Verification Log (Annexure-7).
  2. Segregation of Materials:
    • Segregate raw materials based on their status: Quarantined, Approved, and Rejected.
    • Store incompatible materials separately to prevent cross-contamination.
    • Document segregation practices in the Material Segregation Log (Annexure-8).

5.4 Environmental Controls

  1. Temperature and Humidity Control:
    • Monitor storage conditions daily to ensure materials are kept within specified temperature and humidity ranges.
    • Document environmental conditions in the Temperature and Humidity Log (Annexure-9).
  2. Airflow and Ventilation:
    • Ensure proper airflow in storage areas to prevent condensation and maintain material integrity.
    • Conduct periodic inspections of ventilation systems and document in the Environmental Control Log (Annexure-10).

5.5 Handling Deviations and Corrective Actions

  1. Reporting Deviations:
    • Immediately report any deviations, such as damaged packaging or incorrect storage, to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-11).
  2. Corrective Actions:
    • Investigate the cause of deviations and implement corrective actions, such as re-labeling or relocating materials.
    • Document corrective actions in the Corrective Action Log (Annexure-12).

6. Abbreviations

See also  SOP for Immediate Quarantine of Raw Materials Suspected of Contamination - V 2.0

7. Documents

  1. Receiving Inspection Log (Annexure-1)
  2. Document Compliance Log (Annexure-2)
  3. Drum Storage Log (Annexure-3)
  4. Bag Storage Log (Annexure-4)
  5. Carboy Storage Log (Annexure-5)
  6. General Packaging Storage Log (Annexure-6)
  7. Label Verification Log (Annexure-7)
  8. Material Segregation Log (Annexure-8)
  9. Temperature and Humidity Log (Annexure-9)
  10. Environmental Control Log (Annexure-10)
  11. Deviation Log (Annexure-11)
  12. Corrective Action Log (Annexure-12)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Receiving Inspection Log

Date Material Name Packaging Type Condition at Receipt Inspected By
25/02/2025 API A Drum Good Ravi Kumar

Annexure-2: Document Compliance Log

Date Material Name Document Type Status Verified By
25/02/2025 API A COA Verified 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
25/02/2025 2.0 Updated Procedures for Different Packaging Forms Regulatory Compliance QA Head
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