SOP Guide for Pharma

Elixir Department: SOP for Storage of Raw Materials for Elixir Manufacturing – V 2.0

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Elixir Department: SOP for Storage of Raw Materials for Elixir Manufacturing – V 2.0

Standard Operating Procedure for Storage of Raw Materials for Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/003/2025
Supersedes SOP/ELX/003/2022
Page No. Page 1 of 8
Issue Date 12/04/2025
Effective Date 15/04/2025
Review Date 12/04/2026

1. Purpose

To define the procedure for proper storage of raw materials including APIs, excipients, and solvents used in elixir manufacturing to maintain their quality, identity, strength, and purity throughout the storage duration.

2. Scope

This SOP is applicable to all raw materials received and intended for use in the Elixir Department, stored in designated warehouses under specified conditions until issuance for manufacturing.

3. Responsibilities

  • Warehouse Staff:
    • Ensure proper storage conditions and segregation.
    • Monitor temperature and humidity.
    • Maintain storage records and inventory.
  • Quality Assurance (QA):
    • Ensure compliance with storage SOP and approve material movement between areas.

4. Accountability

The Head of Warehouse and Head of QA are jointly accountable for adherence to this SOP and for the quality of stored materials.

See also  Elixir Department: SOP for Handling Material Spillage in Dispensing Area - V 2.0

5. Procedure

5.1 Warehouse Zoning

  1. Divide the warehouse into the
following designated zones:
  • Quarantine Area
  • Approved Material Storage
  • Rejected Material Area
  • Under Test Area
  • Controlled Substance Area (if applicable)
  • Clearly mark zones and maintain physical barriers as applicable.

    • 5.2 Material Segregation

    1. Store materials by category:
      • APIs separately from excipients and solvents
      • Hazardous materials in accordance with MSDS guidelines
      • Light-sensitive or humidity-sensitive materials in appropriate containers

    5.3 Environmental Conditions

    1. Monitor and record temperature and humidity twice daily using calibrated hygrometers and thermometers.
    2. Standard storage conditions:
      • Ambient: 15°C to 25°C
      • Refrigerated: 2°C to 8°C (if applicable)
      • Humidity: Not more than 60% RH
    3. Take corrective action if deviations occur and notify QA.

    5.4 Material Storage Practice

    1. Place materials on clean, labeled pallets—never directly on the floor.
    2. Ensure labels face outward and are easily visible.
    3. Use FIFO (First In, First Out) or FEFO (First Expiry, First Out) system as appropriate.
    4. Affix status labels:
      • “Under Test” – Before QC release
      • “Approved” – After QC approval
      • “Rejected” – After QC rejection

    5.5 Storage of Volatile and Flammable Materials

    1. Store in flameproof cabinets or designated flameproof areas with ventilation.
    2. Ensure fire extinguishers are available and inspected monthly.

    5.6 Pest Control and Housekeeping

    1. Conduct pest control activities monthly through authorized agencies.
    2. Clean the warehouse floors, shelves, and surroundings daily using dry or damp mopping.
    3. Spillages should be cleaned immediately and reported in the cleaning logbook.

    5.7 Record Keeping

    1. Maintain the following logs:
      • Material Location Log (Annexure-1)
      • Temperature and Humidity Log (Annexure-2)
      • Pest Control Log (Annexure-3)

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • API: Active Pharmaceutical Ingredient
    • MSDS: Material Safety Data Sheet
    • FIFO: First In, First Out
    • FEFO: First Expiry, First Out

    7. Documents

    1. Material Location Log (Annexure-1)
    2. Temperature and Humidity Log (Annexure-2)
    3. Pest Control Log (Annexure-3)

    8. References

    • WHO GMP Guide – Storage of Pharmaceutical Products
    • 21 CFR Part 211.80 – Storage and Distribution
    • ICH Q7 – Good Manufacturing Practice for APIs

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Material Location Log

    Material Name Batch No. Zone Location Code Status Date Stored
    Sodium Benzoate SB/0425/008 Approved Area R-12-A Approved 12/04/2025

    Annexure-2: Temperature and Humidity Log

    Date Time Temperature (°C) Humidity (% RH) Checked By Remarks
    12/04/2025 09:00 23.1 52 Rajesh Kumar Within Limit

    Annexure-3: Pest Control Log

    Date Agency Service Type Service Done By Remarks
    10/04/2025 CleanTech Services Rodent & Insect Control Sunil Patil Completed

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    10/01/2022 1.0 Initial SOP Release New SOP QA Head
    12/04/2025 2.0 Updated zoning and monitoring controls Compliance and clarity QA Head
    See also  Elixir Department: SOP for Control of Cross-Contamination During Dispensing - V 2.0
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